Edwards Alterra Adaptive Prestent System
FDA premarket approval P200015/S022 · decided 2022-07-06
Approval details
- PMA number
- P200015
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Edwards Alterra Adaptive Prestent System
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2022-06-06
- Decision date
- 2022-07-06
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NPV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Changes to the Alterra prestent visual receiving inspection acceptance criteria and the austenite start temperature specification of the nitinol ingots used to manufacture the frame.
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510(k) clearances by this applicant
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|---|---|---|
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