REALITY FEMALE CONDOM
FDA premarket approval P910064/S012 · decided 1995-10-05
Approval details
- PMA number
- P910064
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- REALITY FEMALE CONDOM
- Generic name
- Single-use internal condom
- Applicant
- The Female Health Co.
- Date received
- 1994-11-14
- Decision date
- 1995-10-05
- Days to decision
- 325 days
- Decision code
- APPR
- Product code
- MBU
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Chicago, IL
- Statement
- APPROVAL FOR CHANGES IN THE LABELING "KEY ELEMENTS".
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.