PMA N18286S029
- Device
- Gelfoam (absorbable gelatin)Sterile Sponge
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S029
- Product code
- LMF
- Decision date
- 2018-01-02
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Approval to monitor the water absorption prior to the final device compression manufacturing step.
Current openFDA PMA Record#
- Device
- Gelfoam (absorbable gelatin)Sterile Sponge
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S029
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2018-01-02
- Decision code
- APPR
- Date received
- 2017-02-23
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to monitor the water absorption prior to the final device compression manufacturing step.