PMA P100047S053
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S053
- Product code
- DSQ
- Decision date
- 2015-06-09
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR ALTERNATE BATTERY CELLS AND UPDATED SOFTWARE FOR THE HEARTWAREVENTRICULAR ASSIST DEVICE (HVAD) BATTERY PACK.
Current openFDA PMA Record#
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S053
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2015-06-09
- Decision code
- APPR
- Date received
- 2014-11-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR ALTERNATE BATTERY CELLS AND UPDATED SOFTWARE FOR THE HEARTWAREVENTRICULAR ASSIST DEVICE (HVAD) BATTERY PACK.