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.
Approval for the femcap barrier contraceptive. The femcap is indicated for use by women of childbearing age who desire to prevent or postpone pregnancy.
| Device | FEMCAP BARRIER CONTRACEPTIVE |
| Generic Name | Cap, Cervical, Contraceptive |
| Applicant | FEMCAP, INC. |
| Date Received | 2002-09-30 |
| Decision Date | 2003-03-28 |
| Notice Date | 2003-10-28 |
| PMA | P020041 |
| Supplement | S |
| Product Code | LLQ |
| Docket Number | 03M-0488 |
| Advisory Committee | Obstetrics/Gynecology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | FEMCAP, INC. 14058 Mira Montana Dr. del Mar, CA 92014-3455 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P020041 | Original Filing | |
| S003 | 2013-03-08 | Normal 180 Day Track No User Fee |
| S002 | 2011-07-14 | Normal 180 Day Track No User Fee |
| S001 | 2005-09-02 | Real-time Process |