Purge Cassette
FDA premarket approval P170011/S058 · decided 2025-09-15
Approval details
- PMA number
- P170011
- Supplement
- S058
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Purge Cassette
- Generic name
- Temporary non-roller type right heart support blood pump
- Applicant
- Abiomed, Inc.
- Date received
- 2025-05-15
- Decision date
- 2025-09-15
- Days to decision
- 123 days
- Decision code
- APPR
- Product code
- PYX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- approval for a manufacturing site located at STERIS Applied Sterilization Technologies, 435 Whitney Street, Northborough, MA 01532, which is limited to Ethylene Oxide sterilization of the Purge Cassette, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist devices
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| 14Fr Low Profile Introducer Kit (K252766) | Abiomed, Inc. | 2025-10-08 |
| Abiomed 14Fr Low Profile Introducer Kit (K241708) | Abiomed, Inc. | 2024-08-06 |
| preCARDIA Occlusion System (K221294) | Abiomed, Inc. | 2023-06-30 |
| OXY-1 System (K223161) | Abiomed, Inc. | 2023-02-23 |
| Abiomed 14Fr Low Profile Introducer Set (K222113) | Abiomed, Inc. | 2022-10-13 |
| Impella XR Sheath Set (K202330) | Abiomed, Inc. | 2020-12-07 |
| OXY-1 System (K200109) | Abiomed, Inc. | 2020-10-23 |
| Abiomed 23 Fr Sheath (K201116) | Abiomed, Inc. | 2020-06-15 |