GELFOAM ABSORBABLE GELATIN SPONGE
FDA premarket approval N18286/S020 · decided 2010-10-19
Approval details
- PMA number
- N18286
- Supplement
- S020
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GELFOAM ABSORBABLE GELATIN SPONGE
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Pfizer, Inc.
- Date received
- 2010-10-12
- Decision date
- 2010-10-19
- Days to decision
- 7 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Ny, NY
- Statement
- APPROVAL FOR AN UPDATE TO THE LABELING TO INCLUDE THE CONTRAINDICATION: ¿DO NOT USE GELFOAM ABSORBABLE GELATIN SPONGE IN PATIENTS WITH KNOWN ALLERGIES TO PORCINE COLLAGEN.¿
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| 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 |
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