PMA P100047S044
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S044
- Product code
- DSQ
- Decision date
- 2014-06-27
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR UPDATES TO THE INSTRUCTIONS FOR USE AND PATIENT MANUAL OF THE DEVICE TO INCLUDE INFORMATION RELATED TO BATTERY PERFORMANCE.
Current openFDA PMA Record#
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S044
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2014-06-27
- Decision code
- APPR
- Date received
- 2014-05-29
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR UPDATES TO THE INSTRUCTIONS FOR USE AND PATIENT MANUAL OF THE DEVICE TO INCLUDE INFORMATION RELATED TO BATTERY PERFORMANCE.