THORATEC HEARTMATE 2 LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
FDA premarket approval P060040/S007 · decided 2010-04-06
Approval details
- PMA number
- P060040
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- THORATEC HEARTMATE 2 LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-03-25
- Decision date
- 2010-04-06
- Days to decision
- 12 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR A REPAIR KIT (HM II PLRK) FOR THE EXTERNAL PORTION OF THE HEARTMATE II PERCUTANEOUS LEAD AND A REPAIR KIT (CLAM SHELL) FOR THE EXTERNAL BEND RELIEF.
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