PMA P880047S055

Device: GYNECARE INTERCEED Absorbable Adhesion Barrier
Applicant: ETHICON, Inc.
PMA number: P880047
Supplement: S055
Product code: MCN
Decision date: 2023-11-14
Classification: Obstetrics/Gynecology
Generic name: Barrier, absorbable, adhesion
Approval order statement: Approval for removal of paper Instructions for Use and use of an electronic Instructions for Use for GYNECARE INTERCEED and SURGICEL products.

Current openFDA PMA Record#

Device: GYNECARE INTERCEED Absorbable Adhesion Barrier
Applicant: ETHICON, Inc.
PMA number: P880047
Supplement: S055
Product code: MCN
Generic name: Barrier, absorbable, adhesion
Decision date: 2023-11-14
Decision code: APPR
Date received: 2023-08-22
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for removal of paper Instructions for Use and use of an electronic Instructions for Use for GYNECARE INTERCEED and SURGICEL products.