PMA N18286S023
- Device
- GELFOAM
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S023
- Product code
- LMF
- Decision date
- 2012-03-06
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL FOR UPDATE ON THE MANUFACTURING SITE INFORMATION AND SYMBOLS ON THE LABELS.
Current openFDA PMA Record#
- Device
- GELFOAM
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S023
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2012-03-06
- Decision code
- APPR
- Date received
- 2011-10-13
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR UPDATE ON THE MANUFACTURING SITE INFORMATION AND SYMBOLS ON THE LABELS.