PMA P880047S044

Device
GYNECARE INTERCEED™ Absorbable Adhesion Barrier
Applicant
ETHICON, Inc.
PMA number
P880047
Supplement
S044
Product code
MCN
Decision date
2021-10-21
Generic name
Barrier, absorbable, adhesion
Approval order statement
Changes to the packaging and Bergami process manufacturing steps related to the addition of automated packaging equipment.

Current openFDA PMA Record#

Device
GYNECARE INTERCEED™ Absorbable Adhesion Barrier
Applicant
ETHICON, Inc.
PMA number
P880047
Supplement
S044
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2021-10-21
Decision code
OK30
Date received
2021-09-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes to the packaging and Bergami process manufacturing steps related to the addition of automated packaging equipment.