PMA P880047S066

Device
GYNECARE INTERCEED™ Absorbable Adhesion Barrier
Applicant
ETHICON, Inc.
PMA number
P880047
Supplement
S066
Product code
MCN
Decision date
2025-09-24
Classification
Obstetrics/Gynecology
Generic name
Barrier, absorbable, adhesion
Approval order statement
an update to the raw material inspection process at the San Lorenzo, PR manufacturing site

Current openFDA PMA Record#

Device
GYNECARE INTERCEED™ Absorbable Adhesion Barrier
Applicant
ETHICON, Inc.
PMA number
P880047
Supplement
S066
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2025-09-24
Decision code
OK30
Date received
2025-08-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
an update to the raw material inspection process at the San Lorenzo, PR manufacturing site