THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
FDA premarket approval P060040/S038 · decided 2015-02-12
Approval details
- PMA number
- P060040
- Supplement
- S038
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2015-01-13
- Decision date
- 2015-02-12
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR IMPLEMENTATION OF AN ADDITIONAL EXISTING ELECTRICAL CONTINUITY TEST DURING THE MANUFACTURING PROCESS OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS).
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