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 | FEM CAP |
Generic Name | Cap, cervical, contraceptive |
Applicant | FemCap, Incorporated 23290 Schoenherr Warren, MI 48089 |
PMA Number | P020041 |
Supplement Number | S002 |
Date Received | 07/14/2011 |
Decision Date | 10/13/2011 |
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 HELIX MEDICAL, LLC. IN CARPINTERIA, CA93013 |
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