PMA P080002S001
- Device
- FC2 FEMALE CONDOM
- Applicant
- Clear Future, Inc.
- PMA number
- P080002
- Supplement
- S001
- Product code
- MBU
- Decision date
- 2011-09-23
- Classification
- Single-use Internal Condom
- Generic name
- Single-use internal condom
- Approval order statement
- APPROVAL TO CHANGE THE SHELF LIFE OF THE FC2 FEMALE CONDOM FROM THREE YEARS TO FOUR YEARS.
Current openFDA PMA Record#
- Device
- FC2 FEMALE CONDOM
- Applicant
- Clear Future, Inc.
- PMA number
- P080002
- Supplement
- S001
- Product code
- MBU
- Generic name
- Single-use internal condom
- Decision date
- 2011-09-23
- Decision code
- APPR
- Date received
- 2011-03-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO CHANGE THE SHELF LIFE OF THE FC2 FEMALE CONDOM FROM THREE YEARS TO FOUR YEARS.