Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | FEMCAP BARRIER CONTRACEPTIVE |
Generic Name | Cap, cervical, contraceptive |
Applicant | FemCap, Incorporated 23290 Schoenherr Warren, MI 48089 |
PMA Number | P020041 |
Date Received | 09/30/2002 |
Decision Date | 03/28/2003 |
Product Code |
LLQ |
Docket Number | 03M-0488 |
Notice Date | 10/28/2003 |
Advisory Committee |
Obstetrics/Gynecology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE FEMCAP BARRIER CONTRACEPTIVE. THE FEMCAP IS INDICATED FOR USE BY WOMEN OF CHILDBEARING AGE WHO DESIRE TO PREVENT OR POSTPONE PREGNANCY. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Supplements: |
S001 S002 S003 |
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