THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
FDA premarket approval P060040/S119 · decided 2025-05-21
Approval details
- PMA number
- P060040
- Supplement
- S119
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2025-04-21
- Decision date
- 2025-05-21
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- to replace the existing Vacuum Florescent Display (VFD) Module used in the Heartmate II and Heartmate 3 Universal Battery Charger
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