Product Code: NPT


Products Classified as NPT

1055Aortic Valve, Prosthesis, Percutaneously Delivered

Total Product Life Cycle (TPLC) Devices

1055Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Consensus Standards

Aortic Valve, Prosthesis, Percutaneously Delivered [36800]21 CFR Unclassified 🔎
Aortic Valve, Prosthesis, Percutaneously Delivered [36798]21 CFR Unclassified 🔎

Pre-market Approvals for NPT

P130021CoreValve Evolut R System and CoreValve Evolut PRO SystemMEDTRONIC COREVALVE LLC
P180029LOTUS Edge Valve SystemBoston Scientific Corporation
P130009Edwards SAPIEN XT Transcatheter Heart ValveEDWARDS LIFESCIENCES, LLC.
P140031Edwards SAPIEN 3 Transcatheter Heart Valve and SAPIEN 3 Ultra Transcatheter Heart ValveEDWARDS LIFESCIENCES, LLC.

Global Unique Device Identification Database

00643169987210Aortic valve, prosthesis, percutaneously delivered
00643169987203Aortic valve, prosthesis, percutaneously delivered
00643169987197Aortic valve, prosthesis, percutaneously delivered
00643169987180Aortic valve, prosthesis, percutaneously delivered
00643169987173Aortic valve, prosthesis, percutaneously delivered
00643169956193Aortic valve, prosthesis, percutaneously delivered
00643169954458Aortic valve, prosthesis, percutaneously delivered
00643169954441Aortic valve, prosthesis, percutaneously delivered
00643169954434Aortic valve, prosthesis, percutaneously delivered
00643169934122Aortic valve, prosthesis, percutaneously delivered
00643169934115Aortic valve, prosthesis, percutaneously delivered
00643169800939Aortic valve, prosthesis, percutaneously delivered
00643169800915Aortic valve, prosthesis, percutaneously delivered
00643169792340Aortic valve, prosthesis, percutaneously delivered
00643169640344Aortic valve, prosthesis, percutaneously delivered

Maude Adverse Events

EVOLUT R TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-31
ENVEO PRO DELIVERY SYSTEMMEDTRONIC HEART VALVES DIVISION2020-03-31
EDWARDS ESHEATH INTRODUCER SETEDWARDS LIFESCIENCES2020-03-31
EDWARDS EXPANDABLE INTRODUCER SHEATH SETEDWARDS LIFESCIENCES2020-03-31
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVEEDWARDS LIFESCIENCES2020-03-31
AXELA INTRODUCER SHEATH SETEDWARDS LIFESCIENCES2020-03-31
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVEEDWARDS LIFESCIENCES2020-03-31
LOTUS EDGE VALVE SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-31
LOTUS EDGE VALVE SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-31
EVOLUT PRO PLUS DCSMEDTRONIC HEART VALVES DIVISION2020-03-31
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVEEDWARDS LIFESCIENCES2020-03-31
LOTUS EDGE VALVE SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-31
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVEEDWARDS LIFESCIENCES2020-03-31
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVEEDWARDS LIFESCIENCES2020-03-31
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVEEDWARDS LIFESCIENCES2020-03-31
EVOLUT R TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-31
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVEEDWARDS LIFESCIENCES2020-03-31
EVOLUT R TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-31
EDWARDS EXPANDABLE SHEATH SEEDWARDS LIFESCIENCES2020-03-31
LOTUS EDGE VALVE SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-31
EVOLUT R TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-31
LOTUS EDGE VALVE SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-31
EVOLUT PRO TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-31
LOTUS EDGE VALVE SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-31
EVOLUT PRO TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-31
EVOLUT R TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-31
LOTUS EDGE VALVE SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-31
EVOLUT PRO TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-31
EVOLUT PRO PLUS VALVEMEDTRONIC HEART VALVES DIVISION2020-03-31
EVOLUT R TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-31
EVOLUT R TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-31
EVOLUT R TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-31
EVOLUT R TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-31
EVOLUT PRO TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-31
EVOLUT PRO TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-31
COREVALVE TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-30
EDWARDS SAPIEN TRANSCATHETER HEART VALVEEDWARDS LIFESCIENCES2020-03-30
EVOLUT R TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-30
EVOLUT PRO TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-30
EVOLUT PRO PLUS DCSMEDTRONIC HEART VALVES DIVISION2020-03-30
EVOLUT R TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-30
ENVEO PRO DELIVERY SYSTEMMEDTRONIC HEART VALVES DIVISION2020-03-30
EVOLUT PRO TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-30
EVOLUT PRO TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-30
ENVEO R DELIVERY SYSTEMMEDTRONIC HEART VALVES DIVISION2020-03-30
EVOLUT PRO TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-30
ENVEO PRO DELIVERY SYSTEMMEDTRONIC HEART VALVES DIVISION2020-03-30
EVOLUT PRO TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-30
EVOLUT PRO TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-30
EVOLUT R TRANSCATHETER AORTIC VALVEMEDTRONIC HEART VALVES DIVISION2020-03-30

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