| 2026-07-28 |
P900060-S070 |
CARBOMEDICS PROSTHETIC HEART VALVE, CARBOMEDICS® SUPRA-ANNULAR PROSTHETIC HEART VALVE, OPTIFORM® PROSTHETIC MITRAL HEART |
30-Day Notice |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2025-12-22 |
P150011-S035 |
Perceval Sutureless Heart Valve |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2025-12-17 |
P900060-S069 |
Carbomedics Prosthetic Heart Valve; Carbomedics® Supra-annular Prosthetic Heart Valve; Carbo-Seal® Ascending Aortic Pros |
30-Day Notice |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2025-10-28 |
P150011-S034 |
Perceval Sutureless Heart Valve |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2025-10-28 |
P150011-S033 |
PERCEVAL SUTURELESS HEART VALVE |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2025-05-15 |
P900060-S068 |
CARBOMEDICS Prosthetic Heart Valve; CARBOMEDICS Supra-Annular Prosthetic Heart Valve (Top Hat); ORBIS Prosthetic Heart V |
Normal 180 Day Track |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2025-04-01 |
P150011-S032 |
PERCEVAL SUTURELESS HEART VALVE |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2025-03-12 |
P150011-S028 |
Perceval Sutureless Heart Valve, Perceval Plus Sutureless Heart Valve |
Normal 180 Day Track No User Fee |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2025-01-24 |
P150011-S030 |
Perceval Sutureless Heart Valve, Perceval PLUS Sutureless Heart Valve |
Normal 180 Day Track |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2025-01-21 |
P150011-S031 |
PERCEVAL PLUS SUTURELESS HEART VALVE |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2024-10-17 |
P150011-S029 |
Perceval Plus Sutureless Heart Valve |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2024-07-09 |
P900060-S067 |
Carbomedics Prosthetic Heart Valve, Carbomedics Supra-Annular Prosthetic Heart Valve (Top Hat), Carbo-Seal Ascending Aor |
30-Day Notice |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2024-04-09 |
P900060-S066 |
Carbomedics Prosthetic Heart Valve |
30-Day Notice |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2023-03-02 |
P150011-S027 |
Perceval S Sutureless Heart Valve; Perceval Plus Sutureless Heart Valve |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2023-01-13 |
P900060-S062 |
CARBOMEDICS Prosthetic Heart Valve (CPHV) |
135 Review Track For 30-Day Notice |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2022-11-21 |
P150011-S026 |
Perceval Sutureless Heart Valve |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2022-10-07 |
P150011-S024 |
Perceval PLUS Sutureless Heart Valve |
Normal 180 Day Track |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2022-07-28 |
P150011-S025 |
Perceval Sutureless Heart Valve and Perceval PLUS Sutureless Heart Valve |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2022-03-07 |
P900060-S064 |
Carbomedics® Prosthetic Heart Valve, Carbomedics® Supra-annular Prosthetic Heart Valve (Top Hat), Carbo-Seal® Ascending |
30-Day Notice |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2022-03-07 |
P150011-S023 |
Perceval S Sutureless Heart Valve, Perceval Plus Sutureless Heart Valve |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2021-09-09 |
P900060-S063 |
Carbomedics Prosthetic Heart Valve (CPHV) |
Special (Immediate Track) |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2021-03-17 |
P150011-S022 |
Perceval Sutureless Heart Valve, Perceval PLUS |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2020-10-16 |
P150011-S013 |
Perceval Sutureless Heart Valve |
Normal 180 Day Track |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2020-09-17 |
P900060-S061 |
Carbomedics Prosthetic Heart Valve, Carbo-Seal Ascending Aortic Prosthesis, Carbo-Seal Valsalva Ascending Aortic Prosthe |
135 Review Track For 30-Day Notice |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2020-06-11 |
P150011-S020 |
Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve |
Real-Time Process |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2020-04-03 |
P150011-S019 |
Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2020-02-10 |
P150011-S018 |
Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |