FDA.reportPublic FDA data

PMA P880047S034

Device
Gynecare Interceed Absorbable Adhesion Barrier
Applicant
ETHICON, Inc.
PMA number
P880047
Supplement
S034
Product code
MCN
Decision date
2020-01-30
Generic name
Barrier, absorbable, adhesion
Approval order statement
Addition of GYNECARE INTERCEED Absorbable Adhesion Barrier medium size foil pouches to the upgraded Final Vision System on the automated Foiling Line (G11719) at the Ethicon SARL, Switzerland site for the inspection of hermetically sealed foil pouches.

Current openFDA PMA Record#

Device
Gynecare Interceed Absorbable Adhesion Barrier
Applicant
ETHICON, Inc.
PMA number
P880047
Supplement
S034
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2020-01-30
Decision code
OK30
Date received
2020-01-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of GYNECARE INTERCEED Absorbable Adhesion Barrier medium size foil pouches to the upgraded Final Vision System on the automated Foiling Line (G11719) at the Ethicon SARL, Switzerland site for the inspection of hermetically sealed foil pouches.