Edwards SAPIEN 3 Transcatheter Heart Valve
FDA premarket approval P140031/S067 · decided 2018-07-23
Approval details
- PMA number
- P140031
- Supplement
- S067
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Edwards SAPIEN 3 Transcatheter Heart Valve
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2018-05-29
- Decision date
- 2018-07-23
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for various modifications to the protocols for the "ODE Lead PMA PAS - Continued follow-up of the premarket cohort" of the PIIS3HR and PIIS3i trials.
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