PMA P880047S052

Device: GYNECARE INTERCEED™ Absorbable Adhesion Barrier
Applicant: ETHICON, Inc.
PMA number: P880047
Supplement: S052
Product code: MCN
Decision date: 2022-12-20
Generic name: Barrier, absorbable, adhesion
Approval order statement: Changes related to improvements to the splice detection, vision system, and reject mechanism of the Automated Foil Sealer Equipment (SL1099) used to seal the foil pouches at the ETHICON LLC, San Lorenzo, Puerto Rico manufacturing site.

Current openFDA PMA Record#

Device: GYNECARE INTERCEED™ Absorbable Adhesion Barrier
Applicant: ETHICON, Inc.
PMA number: P880047
Supplement: S052
Product code: MCN
Generic name: Barrier, absorbable, adhesion
Decision date: 2022-12-20
Decision code: OK30
Date received: 2022-11-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes related to improvements to the splice detection, vision system, and reject mechanism of the Automated Foil Sealer Equipment (SL1099) used to seal the foil pouches at the ETHICON LLC, San Lorenzo, Puerto Rico manufacturing site.