KONECT RESILIA Aortic Valved Conduit
FDA premarket approval P150048/S072 · decided 2023-07-12
Approval details
- PMA number
- P150048
- Supplement
- S072
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- KONECT RESILIA Aortic Valved Conduit
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2023-06-12
- Decision date
- 2023-07-12
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Reduction of the seal strength process specification for the foil pouch of the KONECT RESILIA Aortic Valved Conduit.
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510(k) clearances by this applicant
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|---|---|---|
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