Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: REALITY(TM) VAGINAL POUCH
• Generic Name: Single-use internal condom
• Regulation Number: 884.5340
• Applicant: The Female Health Co.; 515 N. State St.; Suite 2225; Chicago, IL 60654
• PMA Number: P910064
• Supplement Number: S002
• Date Received: 05/28/1993
• Decision Date: 07/09/1993
• Withdrawal Date: 09/01/2010
• Product Code: MBU
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No