FDA.reportPublic FDA data

PMA P880047S047

Device
GYNECARE INTERCEED™ Absorbable Adhesion Barrier
Applicant
ETHICON, Inc.
Product code
MCN
Decision date
2022-03-07
Generic name
Barrier, absorbable, adhesion
Approval order statement
Approval for the addition of three additional size varieties (3 inches x 2 inches, 3 inches x 5 inches, and 3 inches x 6 inches) to the GYNECARE INTERCEED Absorbable Adhesion Barrier device line.

Current openFDA PMA Record#

Device
GYNECARE INTERCEED™ Absorbable Adhesion Barrier
Applicant
ETHICON, Inc.
PMA number
P880047
Supplement
S047
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2022-03-07
Decision code
APPR
Date received
2021-11-30
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the addition of three additional size varieties (3 inches x 2 inches, 3 inches x 5 inches, and 3 inches x 6 inches) to the GYNECARE INTERCEED Absorbable Adhesion Barrier device line.