GELFOAM
FDA premarket approval N18286/S028 · decided 2018-03-01
Approval details
- PMA number
- N18286
- Supplement
- S028
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GELFOAM
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Pfizer, Inc.
- Date received
- 2016-04-20
- Decision date
- 2018-03-01
- Days to decision
- 680 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Ny, NY
- Statement
- Approval for an alternative packaging configuration for GELFOAM Sterile Powder under the trade name FLOSTAT NT as well as approval of the associated new manufacturing site for GELFOAM Sterile Powder manufacture (solely for FLOSTAT NT), kit assembly, secondary packaging, and sterilization at Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, Minnesota.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ThermaCare Quick Therapy TENS (K181102) | Pfizer, Inc. | 2018-09-15 |
| VISINE FOR CONTACTS (K991620) | Pfizer, Inc. | 1999-09-24 |
| ORALCHEK SUPER-SOFT BRUSH (K892264) | Pfizer, Inc. | 1989-06-14 |
| WATER JEL STERILE GEL-SOAKED BURN DRESSING (K892360) | Pfizer, Inc. | 1989-06-05 |
| PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE (K881378) | Pfizer, Inc. | 1988-06-17 |
| MEDI-WIPES UNITED ANTISEPTIC SKIN PREP (K854726) | Pfizer, Inc. | 1986-02-24 |
| MEC HIP BOLT (K850413) | Pfizer, Inc. | 1985-07-15 |
| MEC ROD CONNECTOR (K850443) | Pfizer, Inc. | 1985-07-15 |