GELFOAM ABLSORBABLE GELATIN SPONGE AND GELFILM STERILE FILM
FDA premarket approval N18286/S013 · decided 2002-03-20
Approval details
- PMA number
- N18286
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GELFOAM ABLSORBABLE GELATIN SPONGE AND GELFILM STERILE FILM
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Pfizer, Inc.
- Date received
- 2002-02-19
- Decision date
- 2002-03-20
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Ny, NY
- Statement
- CHANGE TO THE BACTERIAL ENDOTOXIN TEST METHOD FOR GELFOAM ABSORBABLE GELATIN SPONGE AND GELFILM STERILE FILM IN ORDER TO COMPLY WITH THE RECENTLY HARMONIZED USP, EP AND JP COMPENDIA FOR BACTERIAL ENDOTOXIN ASSAY.
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510(k) clearances by this applicant
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| 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 |