FILSHIE CLIP(MARK VI) SYSTEM

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Premarket Approval P920046 S008

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 the single use only sterishot ii applicator.

• Device: FILSHIE CLIP(MARK VI) SYSTEM
• Classification Name: Laparoscopic Contraceptive Tubal Occlusion Device
• Generic Name: Laparoscopic Contraceptive Tubal Occlusion Device
• Applicant: FEMCARE LTD.
• Date Received: 2014-06-09
• Decision Date: 2016-12-02
• PMA: P920046
• Supplement: S008
• Product Code: KNH
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: FEMCARE LTD. stuart Court, Spursholt Place, Salisbury Rd romsey hampshire SO516

Supplemental Filings

Supplement Number	Date	Supplement Type
P920046		Original 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 ID	PMA	Supp
05055515602169	P920046	000
05055515602268	P920046	000
05055515602114	P920046	000
05055515602121	P920046	000
05055515602138	P920046	000
05055515602145	P920046	000
05055515602152	P920046	000
15055515602326	P920046	008
15055515602371	P920046	008
25055515600756	P920046	008
25055515602187	P920046	008
15055515602180	P920046	008
25055515602194	P920046	010
15055515602340	P920046	010
15055515602197	P920046	010