PMA N18286S014
- Device
- GELFOAM ABORBABLE GELATIN SPONGE
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S014
- Product code
- LMF
- Decision date
- 2003-04-21
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL FOR MODIFIED LABELING DISCUSSING THE USE OF GELFOAM WITH BOVINE THROMBIN.
Current openFDA PMA Record#
- Device
- GELFOAM ABORBABLE GELATIN SPONGE
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S014
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2003-04-21
- Decision code
- APPR
- Date received
- 2003-03-05
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFIED LABELING DISCUSSING THE USE OF GELFOAM WITH BOVINE THROMBIN.