SEPRAFILM ADHESION BARRIER & SEPRAFILM PROCEDURE PACK
FDA premarket approval P950034/S023 · decided 2003-03-25
Approval details
- PMA number
- P950034
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SEPRAFILM ADHESION BARRIER & SEPRAFILM PROCEDURE PACK
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- Baxter Healthcare Corporation
- Date received
- 2003-02-25
- Decision date
- 2003-03-25
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MCN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Deerfield Lake, IL
- Statement
- THE RETURN OF DISTRIBUTION ACTIVITIES FOR SEPRAFILM ADHESION BARRIER AND SEPRAFILM PROCEDURE PACK TO THE FRAMINGHAM, MASSACHUSETTS, MANUFACTURING FACILITY.
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 |
|---|---|---|
| Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) (K251745) | Baxter Healthcare Corporation | 2025-12-16 |
| SIGMA Spectrum Infusion Pump with Master Drug Library (K251640) | Baxter Healthcare Corporation | 2025-07-28 |
| Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (K251636) | Baxter Healthcare Corporation | 2025-07-28 |
| Solution Administration Sets (K243529) | Baxter Healthcare Corporation | 2025-03-14 |
| Intravascular Extension Sets and Accessories (K242339) | Baxter Healthcare Corporation | 2025-02-28 |
| Novum IQ Syringe Pump (40800BAXUS) (K242390) | Baxter Healthcare Corporation | 2024-09-05 |
| Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS (K241564) | Baxter Healthcare Corporation | 2024-08-02 |
| Novum IQ Large Volume Pump (K211122) | Baxter Healthcare Corporation | 2024-03-29 |