CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPORSTHESIS MODELS 2700TFX, 2800TFX,3000TFX AND 6900PTFX
FDA premarket approval P860057/S032 · decided 2006-03-24
Approval details
- PMA number
- P860057
- Supplement
- S032
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPORSTHESIS MODELS 2700TFX, 2800TFX,3000TFX AND 6900PTFX
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2006-03-03
- Decision date
- 2006-03-24
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR PROTOCOLS TO BE USED TO EXTEND THE SHELF LIFE BEYOND THE CURRENT 2 YEARS.
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