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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.
 
DevicePRENTIF TM CAVITY RIM CERVICAL CAP
Generic NameCap, cervical, contraceptive
ApplicantLamberts Dalston , Ltd.
Dalston House, Hastings St.
Luton, Beds. LU1 5BW
PMA NumberP870062
Supplement NumberS002
Date Received04/03/1991
Decision Date08/20/1991
Product Code LLQ 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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