THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
FDA premarket approval P060040/S024 · decided 2012-10-05
Approval details
- PMA number
- P060040
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2012-08-08
- Decision date
- 2012-10-05
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL TO EXTEND THE SHELF-LIFE OF BOTH THE HEARTMATE II (HM II) SEALED OUTFLOW GRAFT AND THE SEALED INFLOW CONDUIT FROM THE CURRENT LABELING OF THREE YEARS TO FIVE YEARS.
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