PMA P170038S001
- Device
- CentriMag Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S001
- Product code
- DSQ
- Decision date
- 2020-03-20
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Aproval for a manufacturing site located at Gerresheimer Regensburg GmbH in Pfreimd, Germany for assembling and packaging the blood pump.
Current openFDA PMA Record#
- Device
- CentriMag Circulatory Support System
- Applicant
- Abbott
- PMA number
- P170038
- Supplement
- S001
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2020-03-20
- Decision code
- APPR
- Date received
- 2020-01-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Aproval for a manufacturing site located at Gerresheimer Regensburg GmbH in Pfreimd, Germany for assembling and packaging the blood pump.