THORATEC HEARTMATE II LVAS
FDA premarket approval P060040/S021 · decided 2012-06-05
Approval details
- PMA number
- P060040
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THORATEC HEARTMATE II LVAS
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2012-05-04
- Decision date
- 2012-06-05
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR THE HEARTMATE II UNIVERSAL PERCUTANEOUS BEND RELIEF REPAIR KIT.
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