PMA P950034S055

Device
Seprafilm Adhesion Barrier
Applicant
Baxter Healthcare Corporation
PMA number
P950034
Supplement
S055
Product code
MCN
Decision date
2022-12-22
Generic name
Barrier, absorbable, adhesion
Approval order statement
Removal of an In-Process Control as part of the Seprafilm packaging process of counting films

Current openFDA PMA Record#

Device
Seprafilm Adhesion Barrier
Applicant
Baxter Healthcare Corporation
PMA number
P950034
Supplement
S055
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2022-12-22
Decision code
OK30
Date received
2022-11-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Removal of an In-Process Control as part of the Seprafilm packaging process of counting films