EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS
FDA premarket approval P000007/S002 · decided 2002-03-26
Approval details
- PMA number
- P000007
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2001-07-12
- Decision date
- 2002-03-26
- Days to decision
- 257 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE SIZE 29 MM PRIMA PLUS STENTLESS BIOPROSTHESIS.
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