PMA P880047S046

Device: GYNECARE INTERCEED™ Absorbable Adhesion Barrier
Applicant: ETHICON, Inc.
Product code: MCN
Decision date: 2022-06-15
Generic name: Barrier, absorbable, adhesion
Approval order statement: Approval for updates to the device instructions for use and other product labeling related to MRI safety, Carcinogenic, Mutagenic, Toxic to Reproduction (CMR) and Endocrine Disruption (ED) safety, and administrative/clerical changes.

Current openFDA PMA Record#

Device: GYNECARE INTERCEED™ Absorbable Adhesion Barrier
Applicant: ETHICON, Inc.
PMA number: P880047
Supplement: S046
Product code: MCN
Generic name: Barrier, absorbable, adhesion
Decision date: 2022-06-15
Decision code: APPR
Date received: 2021-10-25
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for updates to the device instructions for use and other product labeling related to MRI safety, Carcinogenic, Mutagenic, Toxic to Reproduction (CMR) and Endocrine Disruption (ED) safety, and administrative/clerical changes.