PMA P100047S023
- Device
- HEART WARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S023
- Product code
- DSQ
- Decision date
- 2013-08-30
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR THE HEARTWARE® WAIST PACK AND THE HEARTWARE® SHOULDER PACK.
Current openFDA PMA Record#
- Device
- HEART WARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S023
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2013-08-30
- Decision code
- APPR
- Date received
- 2013-06-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE HEARTWARE® WAIST PACK AND THE HEARTWARE® SHOULDER PACK.