HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
FDA premarket approval P100047/S013 · decided 2013-02-27
Approval details
- PMA number
- P100047
- Supplement
- S013
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2012-12-05
- Decision date
- 2013-02-27
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR ADDITION OF AN ALTERNATE LASER WELDING WORKSTATION AND TO BRING A LASER MARKING STEP IN-HOUSE.
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