PMA P100047S175
- Device
- HeartWare HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S175
- Product code
- DSQ
- Decision date
- 2021-03-11
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Introducing a new solder machine used for the assembly of HVAD power adapters.
Current openFDA PMA Record#
- Device
- HeartWare HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S175
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2021-03-11
- Decision code
- OK30
- Date received
- 2021-02-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introducing a new solder machine used for the assembly of HVAD power adapters.