CentriMag Circulatory Support System
Abbott · Ventricular (assist) bypass · Cardiovascular
Open FDA's page for this record- PMA number
- P170038
- Supplement number
- S034
- Applicant
- Abbott
- Street 1
- 6035 Stoneridge Dr.
- City
- Pleasanton
- State
- CA
- Zip
- 94588
- Generic name
- Ventricular (assist) bypass
- Trade name
- CentriMag Circulatory Support System
- Product code
- DSQ
- Advisory committee
- CV
- Advisory committee description
- Cardiovascular
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2026-09-30
- Decision date
- 2026-10-30
- Decision code
- OK30
- Ao statement
- a manufacturing process change to the routine bioburden monitoring program for the CentriMag Blood Pump
- Harmonized identifiers (openFDA)
- Device name
- Ventricular (Assist) Bypass
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 2916596, 2031044, 2029275, 3012931014, 9612515, 3002807090, 3008454189, 3019807891, 2528981, 3004582654, 1319639, 3007042319, 1927395, 3011823740, 2133810, 3010163695, 2134470, 1721676, 3005228872, 1218444, 3003306248, 2182208, 3008792657
- FEI number
- 1000138054, 2916596, 3012931014, 1000306431, 3008454189, 3006003617, 3019807891, 2528981, 3004582654, 3002808437, 3007042319, 1927395, 3011823740, 3010163695, 3001236763, 1721676, 3000203066, 3005228872, 3002462840, 1218444, 3003306248, 2182208, 3008792657