PMA P880047S045

Device: GYNECARE INTERCEED™ Absorbable Adhesion Barrier
Applicant: ETHICON, Inc.
PMA number: P880047
Supplement: S045
Product code: MCN
Decision date: 2021-10-29
Generic name: Barrier, absorbable, adhesion
Approval order statement: Changes to the sampling frequency of Bacterial Endotoxin Test (BET) lot release testing of the GYNECARE INTERCEED Absorbable Adhesion Barrier device, manufactured at ETHICON SARL, from 100% batch release testing to audit testing on a monthly basis.

Current openFDA PMA Record#

Device: GYNECARE INTERCEED™ Absorbable Adhesion Barrier
Applicant: ETHICON, Inc.
PMA number: P880047
Supplement: S045
Product code: MCN
Generic name: Barrier, absorbable, adhesion
Decision date: 2021-10-29
Decision code: OK30
Date received: 2021-09-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes to the sampling frequency of Bacterial Endotoxin Test (BET) lot release testing of the GYNECARE INTERCEED Absorbable Adhesion Barrier device, manufactured at ETHICON SARL, from 100% batch release testing to audit testing on a monthly basis.