HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
FDA premarket approval P100047/S021 · decided 2013-08-30
Approval details
- PMA number
- P100047
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2013-05-13
- Decision date
- 2013-08-30
- Days to decision
- 109 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL TO MODIFY THE OUTER DIAMETER AND THICKNESS OF THE PUMPS DRIVELINE SHEATH TUBING.
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