PMA P100047S010
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S010
- Product code
- DSQ
- Decision date
- 2013-04-23
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR RE-ROUTING THE THERMAL CUT-OUT WIRE AND SHORTENING THE THERMAL CUT-OUT ASSEMBLY LENGTH.
Current openFDA PMA Record#
- Device
- HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S010
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2013-04-23
- Decision code
- APPR
- Date received
- 2012-12-05
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR RE-ROUTING THE THERMAL CUT-OUT WIRE AND SHORTENING THE THERMAL CUT-OUT ASSEMBLY LENGTH.