PMA P100047S144
- Device
- HeartWare HVAD System
- Applicant
- Medtronic
- Product code
- DSQ
- Decision date
- 2020-04-24
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for a new test system, the HVAD HQ EOL Test System, as the product acceptance test for the HVAD Pump.
Current openFDA PMA Record#
- Device
- HeartWare HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S144
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2020-04-24
- Decision code
- APPR
- Date received
- 2019-08-01
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a new test system, the HVAD HQ EOL Test System, as the product acceptance test for the HVAD Pump.