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: RELIANCE URINARY CONTROL INSERT & SIZING DEVICE
• Generic Name: Transurethral occlusion insert, urinary incontinence-control, female
• Applicant: Uromed Corp.; 64 A St.; Needham, MA 02194
• PMA Number: P960020
• Supplement Number: S001
• Date Received: 03/17/1999
• Decision Date: 04/01/1999
• Product Code: OCK
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for suspension of postapproval study because company is discontinuing manufacture and distribution of device.