PMA P950034S034

Device
SEPRAFILM
Applicant
Baxter Healthcare Corporation
PMA number
P950034
Supplement
S034
Product code
MCN
Decision date
2010-10-07
Generic name
Barrier, absorbable, adhesion
Approval order statement
NEW CLEANING SCHEDULE FOR EQUIPMENT USED IN MANUFACTURING OF THE DEVICE.

Current openFDA PMA Record#

Device
SEPRAFILM
Applicant
Baxter Healthcare Corporation
PMA number
P950034
Supplement
S034
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2010-10-07
Decision code
OK30
Date received
2010-09-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
NEW CLEANING SCHEDULE FOR EQUIPMENT USED IN MANUFACTURING OF THE DEVICE.