PMA P170038S009
- Device
- CentriMag™ Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S009
- Product code
- DSQ
- Decision date
- 2022-04-01
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Add servicing/repair processes for the console and monitor at two existing facilities.
Current openFDA PMA Record#
- Device
- CentriMag™ Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S009
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2022-04-01
- Decision code
- OK30
- Date received
- 2022-03-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add servicing/repair processes for the console and monitor at two existing facilities.