CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS 3000, 3000TFX(AORTIC), 6900P & 6900PTFX(MITRAL)
FDA premarket approval P860057/S037 · decided 2007-02-08
Approval details
- PMA number
- P860057
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS 3000, 3000TFX(AORTIC), 6900P & 6900PTFX(MITRAL)
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2006-09-25
- Decision date
- 2007-02-08
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A REDUCTION IN THE STITCH DENSITY OF THE ANCHOR STITCH SEAMLINE AND FINAL ALTERNATING STITCH SEAMLINE PROCESS OF THE BIOPROSTHETIC STENT SUBASSEMBLY.
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