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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received08/13/2001
Decision Date03/14/2002
Product Code
LLQ[ Registered Establishments with LLQ ]
Docket Number 02M-0471
Notice Date 10/30/2002
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the lea's shield barrier contraceptive. The device is indicated for use by women of childbearing age who desire to prevent or postpone pregnancy.
Approval Order Approval Order
Supplements: S001 
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