CentriMag Circulatory Support System
FDA premarket approval P170038/S016 · decided 2024-05-01
Approval details
- PMA number
- P170038
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CentriMag Circulatory Support System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Abbott
- Date received
- 2024-04-16
- Decision date
- 2024-05-01
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- a change in the bacterial endotoxin testing method
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter (K261825) | Abbott | 2026-07-02 |
| Amplatzer TorqVue Delivery System (K260993) | Abbott | 2026-04-24 |
| Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) (K251221) | Abbott | 2025-09-17 |
| Lingo Glucose System (K233655) | Abbott | 2024-05-29 |
| CentriMag Pre-connected Pack (K222297) | Abbott | 2022-12-01 |
| EnSite X EP System (K221213) | Abbott | 2022-08-18 |
| EnSite X EP System (K212061) | Abbott | 2021-10-22 |
| WorkMate Claris System (K210392) | Abbott | 2021-03-11 |