HEART WARE VENTRICULAR ASSIST SYSTEM
FDA premarket approval P100047/S033 · decided 2014-02-13
Approval details
- PMA number
- P100047
- Supplement
- S033
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HEART WARE VENTRICULAR ASSIST SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2013-11-18
- Decision date
- 2014-02-13
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR USE OF A NEW FORMULATION OF THE THERMOPLASTICVULCANIZATE (TPZ) MATERIAL USED IN THE MANUFACTURE OF THE MONITOR DATA CABLE, BATTERY PACK CABLE, DC ADAPTOR INPUT CABLE, AND ALARM SILENCE ADAPTOR COMPONENTS OF THE DEVICE.
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