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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 BANK APPLICATOR KITS
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantGyrus Acmi, Inc.
136 Tpke. Rd.
Southborough, MA 01772
PMA NumberP870076
Supplement NumberS020
Date Received01/13/2016
Decision Date02/09/2016
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 GA MFG Precision) to C&M Machine for the manufacture of the following components of the subject device: 1) Locating Pin (part number 005267); and 2) Vercap Insert Seal Base (part number 005137).
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