EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS
FDA premarket approval P000007/S034 · decided 2012-10-04
Approval details
- PMA number
- P000007
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2012-09-04
- Decision date
- 2012-10-04
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- MANUFACTURING SOFTWARE CHANGE TO AUTOMATE IN-PROCESS LABELING.
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510(k) clearances by this applicant
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|---|---|---|
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