PMA P880047S040

Device
GYNECARE INTERCEED Absorbable Adhesion Barrier
Applicant
ETHICON, Inc.
PMA number
P880047
Supplement
S040
Product code
MCN
Decision date
2021-04-21
Generic name
Barrier, absorbable, adhesion
Approval order statement
Approval for revisions to the Instructions for Use to include an additional precaution for the GYNECARE INTERCEED Absorbable Adhesion Barrier.

Current openFDA PMA Record#

Device
GYNECARE INTERCEED Absorbable Adhesion Barrier
Applicant
ETHICON, Inc.
PMA number
P880047
Supplement
S040
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2021-04-21
Decision code
APPR
Date received
2021-03-24
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for revisions to the Instructions for Use to include an additional precaution for the GYNECARE INTERCEED Absorbable Adhesion Barrier.