Filshie Clip (Mark VI) System

FDA Premarket Approval P920046 S012

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for revisions to the instructions for use to clarify symptomatic versus asymptomatic clip migration rates for the filshie clip (mark vi) system.

DeviceFilshie Clip (Mark VI) System
Generic NameLaparoscopic Contraceptive Tubal Occlusion Device
ApplicantFEMCARE LTD.
Date Received2021-12-08
Decision Date2022-01-06
PMAP920046
SupplementS012
Product CodeKNH 
Advisory CommitteeObstetrics/Gynecology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address FEMCARE LTD. stuart Court, Spursholt Place, Salisbury Rd romsey hampshire SO516

Supplemental Filings

Supplement NumberDateSupplement Type
P920046Original Filing
S012 2021-12-08 Special (immediate Track)
S011 2019-04-12 Normal 180 Day Track No User Fee
S010 2017-03-01 Real-time Process
S009 2016-03-09 Normal 180 Day Track
S008 2014-06-09 Normal 180 Day Track
S007 2008-12-01 30-day Notice
S006 2008-12-02 Real-time Process
S005 2008-04-14 Normal 180 Day Track No User Fee
S004
S003
S002
S001

NIH GUDID Devices

Device IDPMASupp
05055515602169 P920046 000
05055515602152 P920046 000
05055515602145 P920046 000
05055515602138 P920046 000
05055515602121 P920046 000
05055515602114 P920046 000
25055515600756 P920046 008
25055515602187 P920046 008
15055515602180 P920046 008
15055515602371 P920046 008
25055515602194 P920046 010
15055515602197 P920046 010

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