Approval for a manufacturing site located at 9600 louisiana avenue north, brooklyn park, mn 55445 for the production of the falope ring band.
Device | FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM |
Classification Name | Laparoscopic Contraceptive Tubal Occlusion Device |
Generic Name | Laparoscopic Contraceptive Tubal Occlusion Device |
Applicant | Gyrus ACMI, Inc. |
Date Received | 2015-12-08 |
Decision Date | 2016-03-22 |
PMA | P870076 |
Supplement | S018 |
Product Code | KNH |
Advisory Committee | Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | Gyrus ACMI, Inc. 136 Turnpike Rd. southborough, MA 01772 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P870076 | | Original 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