HEARTMATE II LVAS
FDA premarket approval P060040/S016 · decided 2012-03-29
Approval details
- PMA number
- P060040
- Supplement
- S016
- Supplement type
- Special (Immediate Track)
- Trade name
- HEARTMATE II LVAS
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2012-02-28
- Decision date
- 2012-03-29
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR PROVIDING ADDITIONAL INFORMATION IN THE LABELING REGARDING PROPER ENGAGEMENT OF THE BEND RELIEF WITH THE SEALED OUTFLOW GRAFT OF THE DEVICE AT THE TIME OF IMPLANT.
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