PMA P100047S170
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S170
- Product code
- DSQ
- Decision date
- 2020-09-04
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Change the foreign material (FM) acceptance criteria of the PEEK End Link component at the supplier Donatelle Plastics.
Current openFDA PMA Record#
- Device
- HeartWare Ventricular Assist System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S170
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2020-09-04
- Decision code
- OK30
- Date received
- 2020-08-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the foreign material (FM) acceptance criteria of the PEEK End Link component at the supplier Donatelle Plastics.