ST JUDE MEDICAL MECHANICAL HEART VALVE
FDA premarket approval P810002/S061 · decided 2006-12-20
Approval details
- PMA number
- P810002
- Supplement
- S061
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ST JUDE MEDICAL MECHANICAL HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-11-21
- Decision date
- 2006-12-20
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR CHANGES TO THE EDUCATIONAL BOOKLET FOR ALL PATIENTS RECEIVING A ST. JUDE MEDICAL MECHANICAL HEART VALVE.
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