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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.
 
DeviceFALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM
Generic NameLaparoscopic contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantGyrus Acmi, Inc.
136 Tpke. Rd.
Southborough, MA 01772
PMA NumberP870076
Supplement NumberS003
Date Received10/05/1995
Decision Date03/01/1996
Product Code KNH 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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