PMA P880047S043

Device: GYNECARE INTERCEED™ Absorbable Adhesion Barrier
Applicant: ETHICON, Inc.
Product code: MCN
Decision date: 2022-01-21
Generic name: Barrier, absorbable, adhesion
Approval order statement: Approval for the introduction of a new replacement metal detector for detecting metal particles in the cut Oxidized Regenerated Cellulose (ORC) at your San Lorenzo, Puerto Rico manufacturing site.

Current openFDA PMA Record#

Device: GYNECARE INTERCEED™ Absorbable Adhesion Barrier
Applicant: ETHICON, Inc.
PMA number: P880047
Supplement: S043
Product code: MCN
Generic name: Barrier, absorbable, adhesion
Decision date: 2022-01-21
Decision code: APPR
Date received: 2021-09-03
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the introduction of a new replacement metal detector for detecting metal particles in the cut Oxidized Regenerated Cellulose (ORC) at your San Lorenzo, Puerto Rico manufacturing site.