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. |
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Device | SLEEP SENTRY |
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 | S004 |
Date Received | 04/30/2002 |
Decision Date | 06/12/2003 |
Product Code |
LMY |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE PHYSICAL DESIGN AND LAYOUT OF THE DEVICE, DEVICE LABELING, AND MANUFACTURING FACILITIES AND PROCESSES. THE MANUFACTURING SITES ARE LOCATED AT DIABETES SENTRY PRODUCTS, INC. (DSP), BELLINGHAM WASHINGTON AND DATREND SYSTEMS, INC., RICHMOND, BC CANADA. |
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