PMA P950034S028
- Device
- SEPRAFILM ADHESION BARRIER
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S028
- Product code
- MCN
- Decision date
- 2005-12-05
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- CHANGE IN PERFORMANCE SPECIFICATIONS TO ELIMINATE ETHANOL AND ISOPROPYL ALCOHOL TESTING FROM SEPRAFILM QUALITY CONTROL RELEASE CRITERIA.
Current openFDA PMA Record#
- Device
- SEPRAFILM ADHESION BARRIER
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S028
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2005-12-05
- Decision code
- OK30
- Date received
- 2005-11-18
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE IN PERFORMANCE SPECIFICATIONS TO ELIMINATE ETHANOL AND ISOPROPYL ALCOHOL TESTING FROM SEPRAFILM QUALITY CONTROL RELEASE CRITERIA.