FEMCAP BARRIER CONTRACEPTIVE
FDA premarket approval P020041 · decided 2003-03-28
Approval details
- PMA number
- P020041
- Trade name
- FEMCAP BARRIER CONTRACEPTIVE
- Generic name
- Cap, cervical, contraceptive
- Applicant
- Femcap Incorporated
- Date received
- 2002-09-30
- Decision date
- 2003-03-28
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LLQ
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Warren, MI
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FEMMYCYCLE (K121857) | Femcap Incorporated | 2012-11-15 |