PMA P950034S003

Device
SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE
Applicant
Baxter Healthcare Corporation
PMA number
P950034
Supplement
S003
Product code
MCN
Decision date
1996-12-16
Generic name
Barrier, absorbable, adhesion
Approval order statement
APPROVAL TO EXTEND THE APPROVED 12-MONTH EXPIRATORY PERIOD TO 18 MONTHS.

Current openFDA PMA Record#

Device
SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE
Applicant
Baxter Healthcare Corporation
PMA number
P950034
Supplement
S003
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
1996-12-16
Decision code
APPR
Date received
1996-11-22
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL TO EXTEND THE APPROVED 12-MONTH EXPIRATORY PERIOD TO 18 MONTHS.