THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
FDA premarket approval P060040/S054 · decided 2016-04-05
Approval details
- PMA number
- P060040
- Supplement
- S054
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-03-28
- Decision date
- 2016-04-05
- Days to decision
- 8 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for adding an informational card related to the backup battery.
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