MECHANICAL HEART VALVES
FDA premarket approval P810002/S082 · decided 2012-07-25
Approval details
- PMA number
- P810002
- Supplement
- S082
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MECHANICAL HEART VALVES
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 2012-03-13
- Decision date
- 2012-07-25
- Days to decision
- 134 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE WOODBRIDGE CLEAN ACCESS ENVIRONMENT.
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