HEARTWARE VENTRICULAR ASSIST SYSTEM
FDA premarket approval P100047/S039 · decided 2014-03-14
Approval details
- PMA number
- P100047
- Supplement
- S039
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HEARTWARE VENTRICULAR ASSIST SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2014-02-12
- Decision date
- 2014-03-14
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- SOFTWARE CHANGES TO THE EQUIPMENT USED FOR THE SURFACE TEXTURE AND FORM MEASUREMENTS OF COMPONENTS OF THE HEARTWARE VENTRICULAR ASSIST DEVICE PUMP.
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