CARPENTIER EDWARDS PERIMOUNT PERICARDIAL AOTRIC BIOPROSTHESIS, THEON WITH THERMAFIX TISSUE PROCESS, RSRTHEON
FDA premarket approval P860057/S111 · decided 2013-09-20
Approval details
- PMA number
- P860057
- Supplement
- S111
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARPENTIER EDWARDS PERIMOUNT PERICARDIAL AOTRIC BIOPROSTHESIS, THEON WITH THERMAFIX TISSUE PROCESS, RSRTHEON
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2013-08-20
- Decision date
- 2013-09-20
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- UPDATE TO THE TISSUE FIXATION SYSTEM USING A NEW AUTOMATED PROCESS.
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510(k) clearances by this applicant
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|---|---|---|
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