REGENT MECHANICAL HEART VALVE, STANDARD MECHANICAL HEART VALVE, MASTER MECHANICAL HEART VALVE
FDA premarket approval P810002/S085 · decided 2013-05-30
Approval details
- PMA number
- P810002
- Supplement
- S085
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REGENT MECHANICAL HEART VALVE, STANDARD MECHANICAL HEART VALVE, MASTER MECHANICAL HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 2013-04-30
- Decision date
- 2013-05-30
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- CHANGE TO THE CLEAN ROOM FOR THE SJM MECHANICAL HEART VALVES, AND A CHANGE IN THE VAVGJ PACKAGE SEALING PARAMETERS.
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