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PMA P880047S035

Device
GYNECARE INTERCEED Absorbable Adhesion Barrier
Applicant
ETHICON, Inc.
PMA number
P880047
Supplement
S035
Product code
MCN
Decision date
2020-05-20
Generic name
Barrier, absorbable, adhesion
Approval order statement
Supplier change to increase the quantity of black pigment in the HAPA UV cured ink used to print artwork graphics on the exterior of the GYNECARE INTERCEED Adhesion Barrier foil pouches manufactured on the automated Foiling Line (G11719) at the EthiconSARL, Neuchâtel, Switzerland site.

Current openFDA PMA Record#

Device
GYNECARE INTERCEED Absorbable Adhesion Barrier
Applicant
ETHICON, Inc.
PMA number
P880047
Supplement
S035
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2020-05-20
Decision code
OK30
Date received
2020-04-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Supplier change to increase the quantity of black pigment in the HAPA UV cured ink used to print artwork graphics on the exterior of the GYNECARE INTERCEED Adhesion Barrier foil pouches manufactured on the automated Foiling Line (G11719) at the EthiconSARL, Neuchâtel, Switzerland site.