HEART WARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
FDA premarket approval P100047/S022 · decided 2013-07-03
Approval details
- PMA number
- P100047
- Supplement
- S022
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HEART WARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2013-05-31
- Decision date
- 2013-07-03
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR UPDATES TO THE INSTRUCTIONS FOR USE AND PATIENT MANUAL OF THE DEVICE TO INCLUDE WARNINGS AND INFORMATION RELATED TO ELECTROSTATIC DISCHARGE EXPOSURE AND EXCHANGING POWER SOURCES.
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