FALOPE-RING(R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Premarket Approval P870076 S001

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 a change of sterilization facility to the griffith microscience facility in willowbrook, illinois, for the products including the disposable falope-ring applicator kit with 8mm trocan disposable trocar and cannula, (reorder number 005280-901), and disposable falope-ring applicator kit without 8mm trocan disposable trocar and cannula, (reorder number 006889-901)

DeviceFALOPE-RING(R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
Classification NameLaparoscopic Contraceptive Tubal Occlusion Device
Generic NameLaparoscopic Contraceptive Tubal Occlusion Device
ApplicantGyrus ACMI, Inc.
Date Received1995-09-01
Decision Date1996-01-02
PMAP870076
SupplementS001
Product CodeKNH
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Gyrus ACMI, Inc. 136 Turnpike Rd. southborough, MA 01772

Supplemental Filings

Supplement NumberDateSupplement Type
P870076Original Filing
S027 2021-04-21 30-day Notice
S026 2021-04-16 Special (immediate Track)
S025 2020-04-03 30-day Notice
S024 2020-01-13 30-day Notice
S023 2016-07-18 Real-time Process
S022 2016-03-24 Normal 180 Day Track No User Fee
S021 2016-02-04 30-day Notice
S020 2016-01-13 30-day Notice
S019 2015-12-28 30-day Notice
S018 2015-12-08 Normal 180 Day Track No User Fee
S017 2015-11-02 Normal 180 Day Track
S016 2015-01-22 30-day Notice
S015 2014-11-05 30-day Notice
S014 2014-10-20 Special (immediate Track)
S013 2012-10-04 Special (immediate Track)
S012 2012-06-05 30-day Notice
S011 2010-06-15 30-day Notice
S010 2010-05-04 30-day Notice
S009 2010-01-27 30-day Notice
S008 2006-08-18 Normal 180 Day Track No User Fee
S007 1998-07-27 Normal 180 Day Track
S006 1997-03-11 Normal 180 Day Track
S005 1996-11-27 Normal 180 Day Track
S004 1996-02-07 Normal 180 Day Track
S003 1995-10-05 Normal 180 Day Track
S002
S001 1995-09-01 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00821925032996 P870076 000
00821925032989 P870076 000
00821925032972 P870076 000
00821925028852 P870076 000
00821925000186 P870076 000

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