DIABETES SENTRY
FDA premarket approval P810044/S005 · decided 2005-04-08
Approval details
- PMA number
- P810044
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DIABETES SENTRY
- Generic name
- Monitor, skin resistance/skin temperature, for insulin reactions
- Applicant
- Diabetes Sentry Products, LLC
- Date received
- 2005-02-28
- Decision date
- 2005-04-08
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- LMY
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THE CHANGE OF THE DEVICE WEB ADDRESS, AND A CHANGE TO THE NAME OF THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIABETES SENTRY.
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