| 2026-08-11 |
P110033-S091 |
Juvéderm Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive |
Normal 180 Day Track |
LMH |
— |
— |
| 2026-08-11 |
P050047-S098 |
Ultra, Ultra XC, Ultra Plus XC |
Normal 180 Day Track |
LMH |
— |
— |
| 2026-06-11 |
P110033-S099 |
SKINVIVE by JUVEDERM® |
Panel Track |
LMH |
— |
— |
| 2025-08-14 |
P110033-S101 |
Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC and SKINVIVE by Juvéderm (hereafter ref |
30-Day Notice |
LMH |
— |
— |
| 2025-08-14 |
P050047-S105 |
Juvéderm Ultra XC, and Juvéderm Ultra Plus XC (hereafter referred to as Ultra XC and Ultra Plus XC) |
30-Day Notice |
LMH |
— |
— |
| 2025-07-14 |
P110033-S100 |
Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC and SKINVIVE by Juvéderm (hereafter ref |
30-Day Notice |
LMH |
— |
— |
| 2025-07-14 |
P050047-S104 |
Juvéderm Ultra, Juvéderm Ultra XC, and Juvéderm Ultra Plus XC (hereafter referred to as Ultra, Ultra XC and Ultra Plus X |
30-Day Notice |
LMH |
— |
— |
| 2025-06-25 |
P110033-S085 |
Juvederm Injectable Gel |
Normal 180 Day Track |
LMH |
— |
— |
| 2025-05-08 |
P110033-S098 |
JUVEDERM VOLUMA XC |
Special (Immediate Track) |
LMH |
— |
— |
| 2025-05-01 |
P110033-S097 |
SKINVIVE by Juvéderm |
Special (Immediate Track) |
LMH |
— |
— |
| 2025-04-15 |
P110033-S096 |
Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive |
30-Day Notice |
LMH |
— |
— |
| 2025-04-15 |
P050047-S103 |
Ultra, Ultra XC, Ultra Plus XC, Ultra XC |
30-Day Notice |
LMH |
— |
— |
| 2025-04-01 |
P110033-S095 |
JUVEDERM VOLUMA XC |
30-Day Notice |
LMH |
— |
— |
| 2025-04-01 |
P050047-S102 |
JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS |
30-Day Notice |
LMH |
— |
— |
| 2025-02-18 |
P110033-S093 |
Juvéderm Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive |
30-Day Notice |
LMH |
— |
— |
| 2025-02-18 |
P050047-S100 |
Juvéderm Ultra, Ultra XC, Ultra Plus XC |
30-Day Notice |
LMH |
— |
— |
| 2025-02-12 |
P110033-S094 |
Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC and Skinvive |
30-Day Notice |
LMH |
— |
— |
| 2025-02-12 |
P050047-S101 |
Juvéderm Ultra, Juvéderm Ultra XC, and Juvéderm Ultra Plus XC |
30-Day Notice |
LMH |
— |
— |
| 2025-01-29 |
P110033-S092 |
Juvéderm Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive |
30-Day Notice |
LMH |
— |
— |
| 2025-01-29 |
P050047-S099 |
Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus XC |
30-Day Notice |
LMH |
— |
— |
| 2025-01-17 |
P110033-S090 |
Juvederm Voluma XC |
Normal 180 Day Track |
LMH |
— |
— |
| 2024-12-16 |
P990074-S054 |
NATRELLE Saline-Filled Breast Implants |
30-Day Notice |
FWM |
— |
— |
| 2024-12-16 |
P020056-S065 |
NATRELLE Silicone-Filled Breast Implants |
30-Day Notice |
FTR |
— |
— |
| 2024-12-12 |
P110033-S088 |
Juvederm |
Normal 180 Day Track |
LMH |
— |
— |
| 2024-12-12 |
P050047-S097 |
Juvederm |
Normal 180 Day Track |
LMH |
— |
— |
| 2024-10-29 |
P110033-S089 |
Juvederm Volux XC |
30-Day Notice |
LMH |
— |
— |
| 2024-09-04 |
P110033-S087 |
Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive |
30-Day Notice |
LMH |
— |
— |
| 2024-09-04 |
P050047-S096 |
Ultra, Ultra XC, Ultra Plus XC |
30-Day Notice |
LMH |
— |
— |
| 2024-08-16 |
P020056-S050 |
NATRELLE Silicone-Filled Breast Implants |
Normal 180 Day Track No User Fee |
FTR |
— |
— |
| 2024-06-24 |
P110033-S082 |
Juvederm Volux XC |
Normal 180 Day Track |
LMH |
— |
— |
| 2024-06-21 |
P990074-S053 |
NATRELLE® Saline-Filled Breast Implants |
30-Day Notice |
FWM |
— |
— |
| 2024-06-21 |
P110033-S086 |
Juvederm, Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive |
30-Day Notice |
LMH |
— |
— |
| 2024-06-21 |
P050047-S095 |
Ultra, Ultra XC, Ultra Plus XC |
30-Day Notice |
LMH |
— |
— |
| 2024-06-21 |
P020056-S063 |
NATRELLE® Silicone-Filled Breast Implants |
30-Day Notice |
FTR |
— |
— |
| 2024-05-14 |
P110033-S084 |
Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC |
30-Day Notice |
LMH |
— |
— |
| 2024-05-08 |
P110033-S083 |
Juvéderm Injectable Gel Implants (Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive) |
30-Day Notice |
LMH |
— |
— |
| 2024-05-08 |
P050047-S094 |
Juvéderm Injectable Gel Implants (Ultra, Ultra XC, Ultra Plus XC) |
30-Day Notice |
LMH |
— |
— |
| 2024-05-02 |
P110033-S079 |
JUVÉDERM® VOLUMA ® XC |
Normal 180 Day Track No User Fee |
LMH |
— |
— |
| 2024-01-30 |
P110033-S081 |
Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella, Juvéderm Volux XC, Skinvive |
30-Day Notice |
LMH |
— |
— |
| 2024-01-30 |
P050047-S093 |
Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus XC |
30-Day Notice |
LMH |
— |
— |
| 2023-12-11 |
P110033-S080 |
Juvéderm Voluma XC (Voluma XC), Juvéderm Vollure XC (Vollure XC), Juvéderm Volbella XC (Volbella XC), Juvéderm Volux XC |
30-Day Notice |
LMH |
— |
— |
| 2023-12-11 |
P050047-S092 |
Juvéderm Ultra XC (Ultra XC), Juvéderm Ultra Plus XC (Ultra Plus XC) |
30-Day Notice |
LMH |
— |
— |
| 2023-10-06 |
P110033-S070 |
Juvéderm® Voluma® XC |
Panel Track |
LMH |
— |
— |
| 2023-08-31 |
P110033-S078 |
Juvederm Voluma XC, Juvederm Vollure XC, and Juvederm Volux XC |
30-Day Notice |
LMH |
— |
— |
| 2023-08-31 |
P050047-S091 |
Juvéderm Ultra, Juvéderm Ultra XC, and Juvéderm Ultra Plus XC |
30-Day Notice |
LMH |
— |
— |
| 2023-08-30 |
P110033-S077 |
Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive |
30-Day Notice |
LMH |
— |
— |
| 2023-08-30 |
P050047-S090 |
Ultra, Ultra XC, Ultra Plus XC, Ultra XC |
30-Day Notice |
LMH |
— |
— |
| 2023-08-01 |
P110033-S072 |
SKINVIVE by Juvederm |
Normal 180 Day Track No User Fee |
LMH |
— |
— |
| 2023-07-28 |
P050047-S089 |
Juvéderm Injectable Gel Implant |
30-Day Notice |
LMH |
— |
— |
| 2023-07-12 |
P020056-S061 |
Natrelle Silicone-Filled Breast Implants |
Normal 180 Day Track No User Fee |
FTR |
— |
— |
| 2023-07-06 |
P110033-S076 |
Skinvive by Juvéderm® |
30-Day Notice |
LMH |
— |
— |
| 2023-06-29 |
P110033-S074 |
Skinvive by Juvéderm |
30-Day Notice |
LMH |
— |
— |
| 2023-06-23 |
P110033-S073 |
Skinvive by Juvéderm® |
Special (Immediate Track) |
LMH |
— |
— |
| 2023-06-08 |
P110033-S071 |
Juvéderm® Hyaluronate Gel Implants |
Special (Immediate Track) |
LMH |
— |
— |
| 2023-06-08 |
P050047-S088 |
Juvéderm® Hyaluronate Gel Implants |
Special (Immediate Track) |
LMH |
— |
— |
| 2023-05-11 |
P110033-S059 |
Skinvive by Juvéderm |
Panel Track |
LMH |
— |
— |
| 2023-05-03 |
P110033-S069 |
Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC |
Special (Immediate Track) |
LMH |
— |
— |
| 2023-05-03 |
P050047-S087 |
Juvéderm Ultra, Ultra XC, and Ultra Plus XC, Juvéderm Ultra XC |
Special (Immediate Track) |
LMH |
— |
— |
| 2023-03-16 |
P110033-S063 |
Juvéderm Voluma XC, Juvéderm Vollure XC, Juvederm Volbella XC |
Normal 180 Day Track |
LMH |
— |
— |
| 2023-03-16 |
P050047-S083 |
Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus, Juvéderm Ultra Plus XC |
Normal 180 Day Track |
LMH |
— |
— |
| 2023-02-28 |
P110033-S068 |
Juvéderm® Volux XC |
30-Day Notice |
LMH |
— |
— |
| 2022-12-29 |
P990074-S050 |
NATRELLE Saline-Filled Breast Implants |
Real-Time Process |
FWM |
— |
— |
| 2022-12-29 |
P020056-S059 |
NATRELLE Silicone-Filled Breast Implants |
Real-Time Process |
FTR |
— |
— |
| 2022-10-05 |
P990074-S049 |
NATRELLE Silicone-Filled Breast Implants |
135 Review Track For 30-Day Notice |
FWM |
— |
— |
| 2022-10-05 |
P020056-S058 |
NATRELLE Saline-Filled Breast Implants |
135 Review Track For 30-Day Notice |
FTR |
— |
— |
| 2022-08-05 |
P110033-S067 |
Voluma XC, Vollure XC, Volbella XC |
30-Day Notice |
LMH |
— |
— |
| 2022-08-05 |
P050047-S086 |
Juvéderm Ultra, Ultra XC, Juvéderm Ultra XC |
30-Day Notice |
LMH |
— |
— |
| 2022-07-29 |
P110033-S065 |
Juvéderm Volux XC |
Panel Track |
LMH |
— |
— |
| 2022-04-28 |
P110033-S066 |
Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC |
30-Day Notice |
LMH |
— |
— |
| 2022-04-28 |
P050047-S085 |
Juvéderm Ultra, Ultra XC and Ultra Plus XC, Juvéderm Ultra XC |
30-Day Notice |
LMH |
— |
— |
| 2021-10-27 |
P990074-S045 |
Natrelle Saline Filled Breast Implants |
Normal 180 Day Track |
FWM |
— |
— |
| 2021-10-27 |
P020056-S054 |
Natrelle Silicone Filled Breast Implants |
Normal 180 Day Track |
FTR |
— |
— |
| 2021-09-10 |
P110033-S062 |
Juvéderm® Volbella XC |
Normal 180 Day Track No User Fee |
LMH |
— |
— |
| 2021-07-30 |
P990074-S048 |
NATRELLE Saline-Filled Breast Implants |
30-Day Notice |
FWM |
— |
— |
| 2021-07-30 |
P020056-S057 |
NATRELLE Silicone-Filled Breast Implants |
30-Day Notice |
FTR |
— |
— |
| 2021-07-26 |
P040046-S031 |
NATRELLE Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants |
Normal 180 Day Track No User Fee |
FTR |
— |
— |
| 2021-07-21 |
P110033-S061 |
Juvéderm Voluma XC, Juvéderm Vollure XC, and Juvéderm Volbella XC |
30-Day Notice |
LMH |
— |
— |
| 2021-07-21 |
P110033-S058 |
Juvederm injectable Gel |
135 Review Track For 30-Day Notice |
LMH |
— |
— |
| 2021-07-21 |
P050047-S082 |
Juvéderm Hyaluronate Gel Implants |
30-Day Notice |
LMH |
— |
— |
| 2021-07-21 |
P050047-S080 |
Juvederm Gel Implants |
135 Review Track For 30-Day Notice |
LMH |
— |
— |
| 2021-07-20 |
P990074-S047 |
NATRELLE Saline-Filled Breast Implants |
30-Day Notice |
FWM |
— |
— |
| 2021-07-20 |
P020056-S056 |
NATRELLE Silicone-Filled Breast Implants |
30-Day Notice |
FTR |
— |
— |
| 2021-06-25 |
P990074-S046 |
NATRELLE Silicone-Filled Breast Implants |
30-Day Notice |
FWM |
— |
— |
| 2021-06-25 |
P020056-S055 |
NATRELLE Saline-Filled Breast Implants |
30-Day Notice |
FTR |
— |
— |
| 2021-06-23 |
P110033-S060 |
Juvéderm Hyaluronate Gel Implants |
Special (Immediate Track) |
LMH |
— |
— |
| 2021-06-23 |
P050047-S081 |
Juvéderm Hyaluronate Gel Implants |
Special (Immediate Track) |
LMH |
— |
— |
| 2021-05-28 |
P110033-S053 |
Juvederm Volbella XC |
Panel Track |
LMH |
— |
— |
| 2021-04-10 |
P020056-S053 |
NATRELLE Silicone-Filled Breast Implants |
30-Day Notice |
FTR |
— |
— |
| 2020-11-25 |
P110033-S057 |
Juvéderm Voluma XC, Juvéderm Vollure XC, and Juvéderm Volbella XC |
Special (Immediate Track) |
LMH |
— |
— |
| 2020-11-25 |
P050047-S079 |
Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus, and Juvéderm Ultra Plus XC |
Special (Immediate Track) |
LMH |
— |
— |
| 2020-10-28 |
P110033-S056 |
Juvéderm Injectable Gel Implants |
30-Day Notice |
LMH |
— |
— |
| 2020-10-28 |
P050047-S078 |
Juvéderm Injectable Gel Implants |
30-Day Notice |
LMH |
— |
— |
| 2020-07-30 |
P990074-S044 |
NATRELLE Saline-Filled Breast Implants |
30-Day Notice |
FWM |
— |
— |
| 2020-07-30 |
P040046-S032 |
NATRELLE Style 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants |
30-Day Notice |
FTR |
— |
— |
| 2020-07-30 |
P020056-S051 |
NATRELLE Silicon-Filled Breast Implants |
30-Day Notice |
FTR |
— |
— |
| 2020-07-17 |
P110033-S055 |
Juvéderm Vollure XC and Volbella XC |
Special (Immediate Track) |
LMH |
— |
— |
| 2020-07-17 |
P050047-S077 |
Juvéderm Ultra, Ultra XC, Ultra Plus, and Ultra Plus XC |
Special (Immediate Track) |
LMH |
— |
— |
| 2020-06-12 |
P110033-S047 |
Juvederm Voluma XC for Chin Augmentation |
Panel Track |
LMH |
— |
— |
| 2020-05-28 |
P050047-S076 |
Juvéderm Injectable Gel Implants |
Special (Immediate Track) |
LMH |
— |
— |
| 2020-05-27 |
P110033-S054 |
Juvederm Injectable Gel Implants |
30-Day Notice |
LMH |
— |
— |
| 2020-05-27 |
P050047-S075 |
Juvederm Injectable Gel Implants |
30-Day Notice |
LMH |
— |
— |
| 2020-03-18 |
P110033-S052 |
Juvéderm Voluma XC |
Real-Time Process |
LMH |
— |
— |