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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 NameLEA'S SHIELD BARRIER CONTRACEPTIVE
Classification Namecap, cervical, contraceptive
Generic Namevaginal barrier contraceptive device
ApplicantYAMA, INC.
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
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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