HeartMate 3 Left Ventricular Assist System, HeartMate II Left Ventricular Assist System
FDA premarket approval P160054/S094 · decided 2025-10-17
Approval details
- PMA number
- P160054
- Supplement
- S094
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HeartMate 3 Left Ventricular Assist System, HeartMate II Left Ventricular Assist System
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2025-01-15
- Decision date
- 2025-10-17
- Days to decision
- 275 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for adding another supplier of the Coring Knife sub-assembly and implementing a new cutting test fixture at the supplier and at Abbott receiving inspection.
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