SJM Masters HP Valved Graft
FDA premarket approval P810002/S108 · decided 2020-05-18
Approval details
- PMA number
- P810002
- Supplement
- S108
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SJM Masters HP Valved Graft
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-05-14
- Decision date
- 2020-05-18
- Days to decision
- 735 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for changes related to PET yarn supplier and PET yarn manufacturing.
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