FDA.reportPublic FDA data

PMA P880047S042

Device
GYNECARE INTERCEED™ Absorbable Adhesion Barrier
Applicant
ETHICON, Inc.
PMA number
P880047
Supplement
S042
Product code
MCN
Decision date
2021-09-10
Generic name
Barrier, absorbable, adhesion
Approval order statement
Addition of new and duplicate equipment to support automation of the operations and increase manufacturing capacity at the Ethicon, LLC, San Lorenzo, Puerto Rico facility.

Current openFDA PMA Record#

Device
GYNECARE INTERCEED™ Absorbable Adhesion Barrier
Applicant
ETHICON, Inc.
PMA number
P880047
Supplement
S042
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2021-09-10
Decision code
OK30
Date received
2021-08-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of new and duplicate equipment to support automation of the operations and increase manufacturing capacity at the Ethicon, LLC, San Lorenzo, Puerto Rico facility.