PMA N18286S011
- Device
- GELFOAM ABSORBABLE GELATIN POWDER
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S011
- Product code
- LMF
- Decision date
- 1999-04-26
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Approval for changing the name of the product form Gelfoam Sterile Powder to Gelfoam Absorbable Gelatin Powder.
Current openFDA PMA Record#
- Device
- GELFOAM ABSORBABLE GELATIN POWDER
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S011
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 1999-04-26
- Decision code
- APPR
- Date received
- 1999-04-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changing the name of the product form Gelfoam Sterile Powder to Gelfoam Absorbable Gelatin Powder.