GELFOAM (ABSORABLE GELATIN) POWDER, USP
FDA premarket approval N18286/S024 · decided 2013-01-07
Approval details
- PMA number
- N18286
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GELFOAM (ABSORABLE GELATIN) POWDER, USP
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Pfizer, Inc.
- Date received
- 2012-11-26
- Decision date
- 2013-01-07
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Ny, NY
- Statement
- APPROVAL FOR A MINOR CHANGE IN LABELING INSTRUCTIONS TO INCLUDE MIXING GELFOAM POWDER WITH DILUENTS OF SALINE FOR INJECTION OR THROMBIN. NO OTHER CHANGE INCLUDED IN THIS APPROVAL ORDER. THE DEVICE ALONG WITH THE MODIFIED LABELING WILL BE MARKETED UNDER THE TRADE NAME GELFOAM ABSORBABLE GELATIN POWDER: IS INTENDED AS A HEMOSTATIC DEVICE FOR SURGICAL PROCEDURES WHEN CONTROL OF CAPILLARY, VENOUS AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE, AND OTHER CONVENTIONAL PROCEDURES IS EITHER INEFFECTIVE O
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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 |