THORATEC HEARTMATE 2 LVAS
FDA premarket approval P060040/S006 · decided 2010-04-19
Approval details
- PMA number
- P060040
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THORATEC HEARTMATE 2 LVAS
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-01-25
- Decision date
- 2010-04-19
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR A DESIGN CHANGE TO THE PUMP END BEND RELIEF (PEBR) REGION OF THE HEARTMATE II PERCUTANEOUS LEAD.
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