CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING, CARPENTIER-EDWARDS DURAFLEX LO
FDA premarket approval P870077/S061 · decided 2014-05-19
Approval details
- PMA number
- P870077
- Supplement
- S061
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING, CARPENTIER-EDWARDS DURAFLEX LO
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2014-03-05
- Decision date
- 2014-05-19
- Days to decision
- 75 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR UPGRADING THE PRINTED CIRCUIT BOARD (PCB) OF THESENSITECH AGALERT® TEMPERATURE INDICATOR WITH MINOR HARDWARE ENHANCEMENTS.
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