PMA P170038S005
- Device
- CentriMag Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S005
- Product code
- DSQ
- Decision date
- 2020-08-28
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- CentriMag Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S005
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2020-08-28
- Decision code
- APPR
- Date received
- 2020-07-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.