CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES
FDA premarket approval P860057/S118 · decided 2014-08-04
Approval details
- PMA number
- P860057
- Supplement
- S118
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2014-01-29
- Decision date
- 2014-08-04
- Days to decision
- 187 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A CHANGE IN THE SANITATION FREQUENCY OF THE PROCESS WATER SYSTEM USED AT ONE OF THE MANUFACTURING FACILITIES.
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510(k) clearances by this applicant
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| Respiration Rate algorithm (K251326) | Edwards Lifesciences, LLC | 2026-06-11 |
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