PMA P880047S049

Device: GYNECARE INTERCEED™ Absorbable Adhesion Barrier
Applicant: ETHICON, Inc.
PMA number: P880047
Supplement: S049
Product code: MCN
Decision date: 2022-01-20
Generic name: Barrier, absorbable, adhesion
Approval order statement: Changes to inks used on the packaging components (Tyvek wrapper, foil pouch, carton) of the GYNECARE INTERCEED Absorbable Adhesion Barrier, manufactured at the Ethicon LLC site (Puerto Rico).

Current openFDA PMA Record#

Device: GYNECARE INTERCEED™ Absorbable Adhesion Barrier
Applicant: ETHICON, Inc.
PMA number: P880047
Supplement: S049
Product code: MCN
Generic name: Barrier, absorbable, adhesion
Decision date: 2022-01-20
Decision code: OK30
Date received: 2021-12-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes to inks used on the packaging components (Tyvek wrapper, foil pouch, carton) of the GYNECARE INTERCEED Absorbable Adhesion Barrier, manufactured at the Ethicon LLC site (Puerto Rico).