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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.
 
DeviceFALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
Classification Namelaparoscopic contraceptive tubal occlusion device
Generic Namelaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
Applicant
Gyrus ACMI, Inc.
136 turnpike rd.
southborough, MA 01772
PMA NumberP870076
Supplement NumberS003
Date Received10/05/1995
Decision Date03/01/1996
Product Code
KNH[ Registered Establishments with KNH ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change of sterilization facility to the medical manufacturing corporation, erie, pennsylvania for the products including the falope-ring band:box of 30 sterile procedure kits (reorder nujber 000719-250), and falope-ring band: box of 100 sterile procedure kits (reorder number 001452-901).
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