THORATEC HEARTMATE II LVAS
FDA premarket approval P060040/S001 · decided 2009-03-13
Approval details
- PMA number
- P060040
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THORATEC HEARTMATE II LVAS
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2008-07-01
- Decision date
- 2009-03-13
- Days to decision
- 255 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR NEW EXTERNAL PERIPHERALS TO PROVIDE POWER AND SUPPORT OPERATION FOR THE DEVICE.
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