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. |
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Device | LEA'S SHIELD BARRIER CONTRACEPTIVE |
Generic Name | Cap, cervical, contraceptive |
Applicant | YAMA, INC. P.O. BOX 884 MILLBURN, NJ 07041 |
PMA Number | P010043 |
Supplement Number | S001 |
Date Received | 03/21/2003 |
Decision Date | 05/26/2004 |
Product Code |
LLQ |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 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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