HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (HM II LVAS)
FDA premarket approval P060040/S031 · decided 2014-08-05
Approval details
- PMA number
- P060040
- Supplement
- S031
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (HM II LVAS)
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2014-02-10
- Decision date
- 2014-08-05
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR UPDATING THE HEARTMATE II LVAS INSTRUCTIONS FOR USE TO INCLUDE THE POST-APPROVAL STUDY RESULTS FOR THE DESTINATION THERAPY INDICATION AND TO ADD A DISCUSSION ON PUMP THROMBOSIS.
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