GELFOAM (ABSORBABLE GELATIN) STERILE SPONGE
FDA premarket approval N18286/S021 · decided 2011-07-09
Approval details
- PMA number
- N18286
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GELFOAM (ABSORBABLE GELATIN) STERILE SPONGE
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Pfizer, Inc.
- Date received
- 2011-05-09
- Decision date
- 2011-07-09
- Days to decision
- 61 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Ny, NY
- Statement
- APPROVAL FOR A CHANGE IN SOME OF THE COMPONENTS CONTAINED IN THE GELFOAM PLUS KIT AS WELL AS THE INTRODUCTION OF AN ALTERNATIVE GELFOAM PLUS KIT GELFOAM PLUS COMPRESSED. THE COMPONENT CHANGES WILL SUBSTITUTE PREFILLED SALINE SYRINGES AND A NEEDLELESS TRANSFER DEVICE FOR THE STANDARD SALINE VIALS AND NEEDLE-SYRINGE. THE COMPONENTS HAVE BEEN CLEARED/ APPROVED PREVIOUSLY. THE PURPOSE OF THE GELFOAM PLUS KIT IS TO PROVIDE THE CONVENIENCE OF CO-PACKAGED COLLAGEN SPONGE, SALINE DILUENT AND HUMAN THROM
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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 |