PMA P910064S006
- Device
- REALITY FEMALE CONDOM
- Applicant
- The Female Health Co.
- PMA number
- P910064
- Supplement
- S006
- Product code
- MBU
- Decision date
- 1995-07-24
- Generic name
- Single-use internal condom
- Approval order statement
- APPROVAL OF THE FOCUS GROUP STUDY PROTOCOL TO ASSESS PATIENT COMPREHENSION OF PRODUCT LABELING
Current openFDA PMA Record#
- Device
- REALITY FEMALE CONDOM
- Applicant
- The Female Health Co.
- PMA number
- P910064
- Supplement
- S006
- Product code
- MBU
- Generic name
- Single-use internal condom
- Decision date
- 1995-07-24
- Decision code
- APPR
- Date received
- 1993-08-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL OF THE FOCUS GROUP STUDY PROTOCOL TO ASSESS PATIENT COMPREHENSION OF PRODUCT LABELING