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PMA P880047S032

Device
GYNECARE INTERCEED Absorbable Adhesion Barrier
Applicant
ETHICON, Inc.
PMA number
P880047
Supplement
S032
Product code
MCN
Decision date
2019-07-23
Classification
Barrier, Absorbable, Adhesion
Generic name
Barrier, absorbable, adhesion
Approval order statement
Change to the resin components within the sealant film used in the foil pouch packaging for GYNECARE INTERCEED Absorbable Adhesion Barrier and SURGICEL Absorbable Hemostats during manual and automated manufacturing processes.

Current openFDA PMA Record#

Device
GYNECARE INTERCEED Absorbable Adhesion Barrier
Applicant
ETHICON, Inc.
PMA number
P880047
Supplement
S032
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2019-07-23
Decision code
OK30
Date received
2019-06-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to the resin components within the sealant film used in the foil pouch packaging for GYNECARE INTERCEED Absorbable Adhesion Barrier and SURGICEL Absorbable Hemostats during manual and automated manufacturing processes.