SLEEP SENTRY
FDA premarket approval P810044/S004 · decided 2003-06-12
Approval details
- PMA number
- P810044
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SLEEP SENTRY
- Generic name
- Monitor, skin resistance/skin temperature, for insulin reactions
- Applicant
- Diabetes Sentry Products, LLC
- Date received
- 2002-04-30
- Decision date
- 2003-06-12
- Days to decision
- 408 days
- Decision code
- APPR
- Product code
- LMY
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Fort Worth, TX
- 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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