CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC)
FDA premarket approval P010041 · decided 2002-06-24
Approval details
- PMA number
- P010041
- Trade name
- CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC)
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2001-08-01
- Decision date
- 2002-06-24
- Days to decision
- 327 days
- Decision code
- APWD
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC), WHICH INCLUDES SIZES 21, 23, 25 AND 27MM. THIS DEVICE IS INDICATED FOR PATIENTS WHO REQUIRE REPLACEMENT OF THEIR NATIVE OR PROSTHETIC AORTIC VALVE.
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