EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P
FDA premarket approval P000007 · decided 2001-02-27
Approval details
- PMA number
- P000007
- Trade name
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2000-01-27
- Decision date
- 2001-02-27
- Days to decision
- 397 days
- Decision code
- APWD
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE EDWARDS PRIMA(TM) PLUS STENTLESS BIOPROSTHESIS MODEL 2500P, SIZES 21, 23, 25 AND 27 MM. THE DEVICE IS INDICATED FOR PATIENTS WHO REQUIRE REPLACEMENT OF THEIR NATIVE OR PROSTHETIC AORTIC VALVE USING THE SUBCORONARY IMPLANTATION TECHNIQUE.
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