PMA N18286S036
- Device
- Gelfoam (absorbable gelatin) Sterile Sponge
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S036
- Product code
- LMF
- Decision date
- 2020-12-10
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Addition of Anaphylaxis to the Warnings and Adverse Reactions sections of the Gelfoam Instructions for Use.
Current openFDA PMA Record#
- Device
- Gelfoam (absorbable gelatin) Sterile Sponge
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S036
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2020-12-10
- Decision code
- APPR
- Date received
- 2020-11-10
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Addition of Anaphylaxis to the Warnings and Adverse Reactions sections of the Gelfoam Instructions for Use.