(Gelfoam (absorbable gelatin) Sterile Sponge)
FDA premarket approval N18286/S040 · decided 2022-06-24
Approval details
- PMA number
- N18286
- Supplement
- S040
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- (Gelfoam (absorbable gelatin) Sterile Sponge)
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Pfizer, Inc.
- Date received
- 2022-05-27
- Decision date
- 2022-06-24
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Ny, NY
- Statement
- Approval for updating the Gelfoam Instructions for Use to include language on visualization of the target bleeding site before application and to update the Adverse Reactions section to include duct stenosis (such as bile duct stenosis).
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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 |