- Device
- Gel-Flow NT, Gelfoam Powder, Gelfoam Sponge, Gelfoam Compressed Sponge
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S032
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2019-07-02
- Decision code
- APPR
- Date received
- 2019-06-06
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a change in the labeling to identify the potential risk of pseudotumor appearance associated with device use.