Gambro Prismaflex TPE 2000 Set
FDA premarket approval P830063/S031 · decided 2025-12-23
Approval details
- PMA number
- P830063
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Gambro Prismaflex TPE 2000 Set
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Applicant
- Vantive US Healthcare, LLC
- Date received
- 2025-12-12
- Decision date
- 2025-12-23
- Days to decision
- 11 days
- Decision code
- OK30
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Deerfield, IL
- Statement
- a new mold for the soft extension pierceable component of the Prismaflex TPE 2000 set
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| AK 98 Dialysis Machine (955607) (K250508) | Vantive US Healthcare, LLC | 2025-08-01 |