EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2500P
FDA premarket approval P000007/S015 · decided 2008-05-23
Approval details
- PMA number
- P000007
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2500P
- Generic name
- replacement Heart-valve
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2008-03-24
- Decision date
- 2008-05-23
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO EXTEND THE USE OF THE SENSITECH TAGALERT TEMPERATURE ALARM INDICATOR ON THE DEVICE PACKAGING FROM TRANSIT ONLY TO BOTH TRANSIT AND STORAGE UP TO FOUR (4) YEARS.
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