PMA P100047S072
- Device
- HEARTWARE VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S072
- Product code
- DSQ
- Decision date
- 2016-03-17
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Automation of an existing manufacturing process via software revision for the HeartWare Ventricular Assist Device (HVAD).
Current openFDA PMA Record#
- Device
- HEARTWARE VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S072
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2016-03-17
- Decision code
- OK30
- Date received
- 2016-02-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automation of an existing manufacturing process via software revision for the HeartWare Ventricular Assist Device (HVAD).