SJM Masters Series Mechanical Heart Valve, 15mm HP
FDA premarket approval P810002/S119 · decided 2023-12-04
Approval details
- PMA number
- P810002
- Supplement
- S119
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- SJM Masters Series Mechanical Heart Valve, 15mm HP
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 2023-06-07
- Decision date
- 2023-12-04
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for modifications to the Instructions for Use to reflect the 5-year findings of the Post-Approval Study (PAS) Report submitted for the continued follow-up of the premarket HALO cohort
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