FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Ventricular (Assist) Bypass
PMA: P170038
·
Supplement: S025
·
Decision Dec 1, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Ventricular (Assist) Bypass
- Trade Name
- CentriMag Circulatory Support System
- PMA Number
- P170038
- Supplement Number
- S025
- Device Class
- FDA Class 3
- Product Code
- DSQ
- Generic Name
- Ventricular (assist) bypass
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 1, 2025
- Date Received
- July 2, 2025
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - PAS
- Expedited Review
- N
Advisory Committee Statement
approval of changes to the CentriMag Circulatory Support System Clinical Reference Manual to include information on the CentriMag FTW Post-Approval Study
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSQ | Ventricular (Assist) Bypass | FDA class 3 | Unknown |