CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS
FDA premarket approval P870077/S013 · decided 2003-05-09
Approval details
- PMA number
- P870077
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2002-11-12
- Decision date
- 2003-05-09
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE REPLACEMENT OF THE PACKAGE TEMPERATURE INDICATOR TO THE TAGALERT ELECTRONIC TEMPERATURE INDICATOR (HIGH AND LOW).
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