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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.
 
Trade NameFALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
Classification Namedevice, occlusion, tubal, contraceptive
Generic Nametubal occlusion device
Regulation Number884.5380
ApplicantCABOT MEDICAL CORP.
PMA NumberP870076
Supplement NumberS004
Date Received02/07/1996
Decision Date06/14/1996
Product Code
KNH[ Registered Establishments with KNH ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing site on circon-cabot medical's racine, wisconsin facility for 1) disposable falope-ring applicator kit with 8mm trocar disposable trocar, and cannula: box of 8 sterile procedure kits (re-order number 005280-901); and 2) disposable falope-ring applicator kit without 8mm trocar, disposable trocar, and cannula: box of 8 sterile procedure kits (re-order number 006889-901).
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