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.
Approval for a protocol to extend the shelf life of the femcap contraceptive barrier from three years to five years.
| Device | FEMCAP CONTRACEPTIVE BARRIER DEVICE |
| Generic Name | Cap, Cervical, Contraceptive |
| Applicant | FEMCAP, INC. |
| Date Received | 2005-09-02 |
| Decision Date | 2006-02-15 |
| PMA | P020041 |
| Supplement | S001 |
| Product Code | LLQ |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | FEMCAP, INC. 14058 Mira Montana Dr. del Mar, CA 92014-3455 |
| 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 |