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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namedevice, occlusion, tubal, contraceptive, laparoscopic
Generic Namedevice, occlusion, tubal, contraceptive, laparoscopic
Regulation Number884.5380
Gyrus ACMI, Inc.
136 turnpike rd.
southborough, MA 01772
PMA NumberP870076
Supplement NumberS007
Date Received07/27/1998
Decision Date03/02/1999
Product Code
KNH[ Registered Establishments with KNH ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for dimensional and design changes of the falope-ring(r) applicators.