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 | FEMCAP CONTRACEPTIVE BARRIER DEVICE |
Generic Name | Cap, cervical, contraceptive |
Applicant | FemCap, Incorporated 23290 Schoenherr Warren, MI 48089 |
PMA Number | P020041 |
Supplement Number | S001 |
Date Received | 09/02/2005 |
Decision Date | 02/15/2006 |
Product Code |
LLQ |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A PROTOCOL TO EXTEND THE SHELF LIFE OF THE FEMCAP CONTRACEPTIVE BARRIER FROM THREE YEARS TO FIVE YEARS. |
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