Gel-Flow NT, Gelfoam Powder, Gelfoam Sponge, Gelfoam Compressed Sponge
FDA premarket approval N18286/S032 · decided 2019-07-02
Approval details
- PMA number
- N18286
- Supplement
- S032
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Gel-Flow NT, Gelfoam Powder, Gelfoam Sponge, Gelfoam Compressed Sponge
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Pfizer, Inc.
- Date received
- 2019-06-06
- Decision date
- 2019-07-02
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Ny, NY
- Statement
- Approval for a change in the labeling to identify the potential risk of pseudotumor appearance associated with device use.
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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 |