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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 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.
 
DeviceDISPOSABLE FALOPE-RING BAND APPLICATOR KITS
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantGyrus Acmi, Inc.
136 Tpke. Rd.
Southborough, MA 01772
PMA NumberP870076
Supplement NumberS019
Date Received12/28/2015
Decision Date01/27/2016
Product Code KNH 
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN SUPPLIERS FROM SENIOR OPERATIONS LLC (FORMERLY KNOWN AS GORMAC PRODUCTS) TO GYRUS ACMI NORWALK, OH FACILITY (ESTABLISHMENT REGISTRATION NUMBER 1519132) FOR THE MANUFACTURE OF THE FOLLOWING COMPONENTS OF YOUR DEVICE: FALOPE RING BAND APPLICATOR FORCEPS INNER TUBE (PART NUMBER 005261); OUTER TUBE (PART NUMBER 005262); AND CANNULA SLEEVE (PART NUMBER 004557-3).
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