FEMCAP CONTRACEPTIVE BARRIER DEVICE
FDA premarket approval P020041/S001 · decided 2006-02-15
Approval details
- PMA number
- P020041
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FEMCAP CONTRACEPTIVE BARRIER DEVICE
- Generic name
- Cap, cervical, contraceptive
- Applicant
- Femcap Incorporated
- Date received
- 2005-09-02
- Decision date
- 2006-02-15
- Days to decision
- 166 days
- Decision code
- APPR
- Product code
- LLQ
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Warren, MI
- 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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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FEMMYCYCLE (K121857) | Femcap Incorporated | 2012-11-15 |