HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
FDA premarket approval P100047/S032 · decided 2014-03-26
Approval details
- PMA number
- P100047
- Supplement
- S032
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2013-12-06
- Decision date
- 2014-03-26
- Days to decision
- 110 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A CHANGE OF THE THREAD LOCKING ADHESIVE USED ON THERETENTION NUT WHICH SECURES THE CONNECTOR TO THE CONTROLLER HOUSING.
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