PMA P950034S025
- Device
- SEPRAFILM ADHESION BARRIER/SEPRAFILM PROCEDURE PACK
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S025
- Product code
- MCN
- Decision date
- 2003-05-28
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- MANUFACTURING PROCESS CHANGE TO EXTEND THE ENDOTOXIN SPECIFICATION LIMIT OF HYALURONIC ACID (HA) RAW MATERIAL FROM <=0.04 EU/MG TO <=0.08 EU/MG.
Current openFDA PMA Record#
- Device
- SEPRAFILM ADHESION BARRIER/SEPRAFILM PROCEDURE PACK
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S025
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2003-05-28
- Decision code
- OK30
- Date received
- 2003-04-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING PROCESS CHANGE TO EXTEND THE ENDOTOXIN SPECIFICATION LIMIT OF HYALURONIC ACID (HA) RAW MATERIAL FROM