PMA P170038S006
- Device
- CentriMag Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S006
- Product code
- DSQ
- Decision date
- 2021-08-05
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Implementation of a new set of mandrels for the CentriMag cannulae body manufacturing process.
Current openFDA PMA Record#
- Device
- CentriMag Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S006
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2021-08-05
- Decision code
- OK30
- Date received
- 2021-07-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a new set of mandrels for the CentriMag cannulae body manufacturing process.