ST JUDE MEDICAL REGENT MECHANICAL HEART VALVE
FDA premarket approval P810002/S068 · decided 2008-11-14
Approval details
- PMA number
- P810002
- Supplement
- S068
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ST JUDE MEDICAL REGENT MECHANICAL HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 2008-10-14
- Decision date
- 2008-11-14
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR MODIFICATIONS AND REARRANGEMENT OF THE INSTRUCTIONS FOR USE (IFU).
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