St. Jude Medical Masters Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Valves Graft
FDA premarket approval P810002/S109 · decided 2019-03-25
Approval details
- PMA number
- P810002
- Supplement
- S109
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- St. Jude Medical Masters Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Valves Graft
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-02-27
- Decision date
- 2019-03-25
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Modification to the air quality testing method and air microbe action and alert levels.
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