PMA P100047S019
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S019
- Product code
- DSQ
- Decision date
- 2013-05-22
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR A CHANGE OF THE ADHESIVE TAPE AND THE ADDITION OF 4 RIBS (POSTS/SHELVES) TO HOLD THE LCD GLASS IN ITS POSITION ON THE CONTROLLER.
Current openFDA PMA Record#
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S019
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2013-05-22
- Decision code
- APPR
- Date received
- 2013-04-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE OF THE ADHESIVE TAPE AND THE ADDITION OF 4 RIBS (POSTS/SHELVES) TO HOLD THE LCD GLASS IN ITS POSITION ON THE CONTROLLER.