REALITY FEMALE CONDOM
FDA premarket approval P910064/S004 · decided 1995-07-24
Approval details
- PMA number
- P910064
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- REALITY FEMALE CONDOM
- Generic name
- Single-use internal condom
- Applicant
- The Female Health Co.
- Date received
- 1993-07-12
- Decision date
- 1995-07-24
- Days to decision
- 742 days
- Decision code
- APPR
- Product code
- MBU
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Chicago, IL
- Statement
- PROVIDED ADD'L DATA ON THE IN VITRO BARRIER PROPERTIES OF THE DEVICE WITH RESPECT TO SEXUALLY TRANSMITTED DISEASES. THESE DATA WERE PROVIDED IN SATISFACTION OF THE CONDITIONS OF APPROVAL CONTAINED IN FDA'S MAY 7, 1993 LETTER
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.