PMA P920046S011

Device
Filshie Clip (Mark VI) System
Applicant
Femcare , Ltd.
PMA number
P920046
Supplement
S011
Product code
KNH
Decision date
2019-10-09
Classification
Laparoscopic Contraceptive Tubal Occlusion Device
Generic name
Laparoscopic contraceptive tubal occlusion device
Approval order statement
Approval for a manufacturing site change for the Filshie Clip System Classic Applicator.

Current openFDA PMA Record#

Device
Filshie Clip (Mark VI) System
Applicant
Femcare , Ltd.
PMA number
P920046
Supplement
S011
Product code
KNH
Generic name
Laparoscopic contraceptive tubal occlusion device
Decision date
2019-10-09
Decision code
APPR
Date received
2019-04-12
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site change for the Filshie Clip System Classic Applicator.