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: SLEEP SENTRY(TM)
• Generic Name: Monitor, skin resistance/skin temperature, for insulin reactions
• Applicant: Diabetes Sentry Products, LLC; 501 Samuels Ave.; Unit #100; Fort Worth, TX 76102
• PMA Number: P810044
• Supplement Number: S001
• Date Received: 11/23/1982
• Decision Date: 09/13/1983
• Product Code: LMY
• Advisory Committee: General Hospital
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No