PMA P950034S036

Device
SEPRAFILM
Applicant
Baxter Healthcare Corporation
PMA number
P950034
Supplement
S036
Product code
MCN
Decision date
2010-12-02
Generic name
Barrier, absorbable, adhesion
Approval order statement
UPGRADES MADE IN MANUFACTURING AREAS AND EQUIPMENT.

Current openFDA PMA Record#

Device
SEPRAFILM
Applicant
Baxter Healthcare Corporation
PMA number
P950034
Supplement
S036
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2010-12-02
Decision code
OK30
Date received
2010-10-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
UPGRADES MADE IN MANUFACTURING AREAS AND EQUIPMENT.