PMA P920046S013

Device
Filshie Clip System
Applicant
Femcare , Ltd.
PMA number
P920046
Supplement
S013
Product code
KNH
Decision date
2023-12-18
Classification
Obstetrics/Gynecology
Generic name
Laparoscopic contraceptive tubal occlusion device
Approval order statement
approval for transfer of manufacturing and packaging processes for the Filshie Clip

Current openFDA PMA Record#

Device
Filshie Clip System
Applicant
Femcare , Ltd.
PMA number
P920046
Supplement
S013
Product code
KNH
Generic name
Laparoscopic contraceptive tubal occlusion device
Decision date
2023-12-18
Decision code
APPR
Date received
2023-04-12
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval for transfer of manufacturing and packaging processes for the Filshie Clip