PMA N18286S038
- Device
- Gelfoam (absorbable gelatin) Sterile Sponge
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S038
- Product code
- LMF
- Decision date
- 2021-05-07
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Approval for addition of text to the Instructions for Use regarding CSF retention and hydrocephalus.
Current openFDA PMA Record#
- Device
- Gelfoam (absorbable gelatin) Sterile Sponge
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S038
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2021-05-07
- Decision code
- APPR
- Date received
- 2021-04-09
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for addition of text to the Instructions for Use regarding CSF retention and hydrocephalus.