CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS
FDA premarket approval P860057/S053 · decided 2009-12-08
Approval details
- PMA number
- P860057
- Supplement
- S053
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2008-12-17
- Decision date
- 2009-12-08
- Days to decision
- 356 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR HARMONIZING THE CENTRAL HOLE DIAMETER, HARMONIZING THE WIREFORM CUSP DIAMETER AND ADDING AORTIC COMMISSURE TIP ANGLE AND COMMISSURE TIP RADIUS INSPECTIONS.
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