PMA P100047S080
- Device
- HEARTWARE VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S080
- Product code
- DSQ
- Decision date
- 2016-09-07
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Additional coating chamber at the existing coating supplier for processing components of the HVAD.
Current openFDA PMA Record#
- Device
- HEARTWARE VENTRICULAR ASSIST DEVICE SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S080
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2016-09-07
- Decision code
- OK30
- Date received
- 2016-08-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional coating chamber at the existing coating supplier for processing components of the HVAD.