PMA P920046S008

Device
FILSHIE CLIP(MARK VI) SYSTEM
Applicant
Femcare , Ltd.
PMA number
P920046
Supplement
S008
Product code
KNH
Decision date
2016-12-02
Classification
Laparoscopic Contraceptive Tubal Occlusion Device
Generic name
Laparoscopic contraceptive tubal occlusion device
Approval order statement
Approval for the single use only Sterishot II Applicator.

Current openFDA PMA Record#

Device
FILSHIE CLIP(MARK VI) SYSTEM
Applicant
Femcare , Ltd.
PMA number
P920046
Supplement
S008
Product code
KNH
Generic name
Laparoscopic contraceptive tubal occlusion device
Decision date
2016-12-02
Decision code
APPR
Date received
2014-06-09
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the single use only Sterishot II Applicator.