PMA P100047S135
- Device
- HeartWare Ventricular Assist System (HVAD)
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S135
- Product code
- DSQ
- Decision date
- 2019-03-13
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for the addition of two 100% in process and incoming inspections at a tier two supplier of the HVAD Battery Charger PCB.
Current openFDA PMA Record#
- Device
- HeartWare Ventricular Assist System (HVAD)
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S135
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2019-03-13
- Decision code
- APPR
- Date received
- 2019-02-19
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of two 100% in process and incoming inspections at a tier two supplier of the HVAD Battery Charger PCB.