PMA N18286S037
- Device
- Gelfoam Sterile Sponge
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S037
- Product code
- LMF
- Decision date
- 2021-02-24
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Approval for addition of text to the Gelfoam Instructions for Use regarding the unapproved use of absorbable gelatin for embolization
Current openFDA PMA Record#
- Device
- Gelfoam Sterile Sponge
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S037
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2021-02-24
- Decision code
- APPR
- Date received
- 2021-01-25
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for addition of text to the Gelfoam Instructions for Use regarding the unapproved use of absorbable gelatin for embolization