PMA P100047S089
- Device
- HEARTWARE VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S089
- Product code
- DSQ
- Decision date
- 2017-05-12
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for the addition of an alternate supplier for a component of the HeartWare Ventricular Assist System Pump.
Current openFDA PMA Record#
- Device
- HEARTWARE VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S089
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2017-05-12
- Decision code
- APPR
- Date received
- 2016-11-21
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of an alternate supplier for a component of the HeartWare Ventricular Assist System Pump.