PMA P880047S060

Device
GYNECARE INTERCEED ™ Absorbable Adhesion Barrier
Applicant
ETHICON, Inc.
PMA number
P880047
Supplement
S060
Product code
MCN
Decision date
2024-06-13
Classification
Obstetrics/Gynecology
Generic name
Barrier, absorbable, adhesion
Approval order statement
to replace the existing sub-component critical supplier of Tyvek Wrapper components used for primary packaging

Current openFDA PMA Record#

Device
GYNECARE INTERCEED ™ Absorbable Adhesion Barrier
Applicant
ETHICON, Inc.
PMA number
P880047
Supplement
S060
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2024-06-13
Decision code
OK30
Date received
2024-05-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
to replace the existing sub-component critical supplier of Tyvek Wrapper components used for primary packaging