CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS,CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOP
FDA premarket approval P860057/S125 · decided 2014-06-18
Approval details
- PMA number
- P860057
- Supplement
- S125
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS,CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOP
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2014-05-23
- Decision date
- 2014-06-18
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- EXPANSION OF A CLEAN ROOM AT THE EDWARDS SINGAPORE MANUFACTURING FACILITY AND THE ADDITION OF ASSOCIATED EQUIPMENT FOR USE IN THE EXISTING CLEAN ROOM.
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