PMA P170038S010
- Device
- CentriMag™ Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S010
- Product code
- DSQ
- Decision date
- 2022-05-11
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Add an alternate sub-tier supplier for the PTFE felt material used to manufacture the Apical Sewing Ring for the CentriMag Cannula Drainage Kit.
Current openFDA PMA Record#
- Device
- CentriMag™ Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S010
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2022-05-11
- Decision code
- OK30
- Date received
- 2022-04-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate sub-tier supplier for the PTFE felt material used to manufacture the Apical Sewing Ring for the CentriMag Cannula Drainage Kit.