PMA N18286S030
- Device
- Gel-Flow NT
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S030
- Product code
- LMF
- Decision date
- 2018-04-13
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Approval for a change in the device name from Flostat NT to Gel-Flow NT.
Current openFDA PMA Record#
- Device
- Gel-Flow NT
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S030
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2018-04-13
- Decision code
- APPR
- Date received
- 2018-03-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a change in the device name from Flostat NT to Gel-Flow NT.