PMA P950034S042

Device
SEPRAFILM ADHESION BARRIER
Applicant
Baxter Healthcare Corporation
PMA number
P950034
Supplement
S042
Product code
MCN
Decision date
2014-08-12
Generic name
Barrier, absorbable, adhesion
Approval order statement
ADDITIONAL SITE FOR QUARTERLY IRRADIATION DOSE VERIFICATION FOR THE SEPRAFILM ADHESION BARRIER.

Current openFDA PMA Record#

Device
SEPRAFILM ADHESION BARRIER
Applicant
Baxter Healthcare Corporation
PMA number
P950034
Supplement
S042
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2014-08-12
Decision code
OK30
Date received
2014-07-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITIONAL SITE FOR QUARTERLY IRRADIATION DOSE VERIFICATION FOR THE SEPRAFILM ADHESION BARRIER.