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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.
 
DeviceLEA'S SHIELD BARRIER CONTRACEPTIVE
Classification Namecap, cervical, contraceptive
Generic Namecap, cervical, contraceptive
Applicant
YAMA, INC.
p.o. box 884
millburn, NJ 07041
PMA NumberP010043
Supplement NumberS001
Date Received03/21/2003
Decision Date05/26/2004
Product Code
LLQ[ Registered Establishments with LLQ ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at yama, inc. , union, new jersey.
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