PMA N18286S027
- Device
- GELFOAM PLUS HEMOSTATS KITS
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S027
- Product code
- LMF
- Decision date
- 2014-11-04
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- PROPOSED ADDITION OF AN ALTERNATE PRODUCTION AREA FOR GELFOAM BULK SOLUTION MANUFACTURING.
Current openFDA PMA Record#
- Device
- GELFOAM PLUS HEMOSTATS KITS
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S027
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2014-11-04
- Decision code
- OK30
- Date received
- 2014-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- PROPOSED ADDITION OF AN ALTERNATE PRODUCTION AREA FOR GELFOAM BULK SOLUTION MANUFACTURING.