FEM CAP
FDA premarket approval P020041/S002 · decided 2011-10-13
Approval details
- PMA number
- P020041
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FEM CAP
- Generic name
- Cap, cervical, contraceptive
- Applicant
- Femcap Incorporated
- Date received
- 2011-07-14
- Decision date
- 2011-10-13
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- LLQ
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Warren, MI
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT HELIX MEDICAL, LLC. IN CARPINTERIA, CA93013
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FEMMYCYCLE (K121857) | Femcap Incorporated | 2012-11-15 |