PMA P050012S001
- Device
- SEVEN PLUS CONTINOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S001
- Product code
- MDS
- Decision date
- 2007-05-31
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- APPROVAL FOR THE STS-7 CONTINUOUS GLUCOSE MONITORING SYSTEM (STS-7 SYSTEM). THE DEVICE IS INDICATED FOR THE FOLLOWING: THE STS-7 CONTINUOUS GLUCOSE MONITORING SYSTEM (STS-7 SYSTEM) IS A GLUCOSE-MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN ADULTS (AGE 18 AND OLDER) WITH DIABETES. THE STS-7 SYSTEM IS INTENDED FOR USE BY PATIENTS AT HOME AND IN HEALTH CARE FACILITIES. THE DEVICE IS FOR PRESCRIPTION USE ONLY. THE STS-7 CONTINUOUS GLUCOSE MONITORING SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE STS-7 CONTINUOUS GLUCOSE MONITORING SYSTEM AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF THE STS-7 SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050012S001B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- SEVEN PLUS CONTINOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S001
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2007-05-31
- Decision code
- APPR
- Date received
- 2006-06-19
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE STS-7 CONTINUOUS GLUCOSE MONITORING SYSTEM (STS-7 SYSTEM). THE DEVICE IS INDICATED FOR THE FOLLOWING: THE STS-7 CONTINUOUS GLUCOSE MONITORING SYSTEM (STS-7 SYSTEM) IS A GLUCOSE-MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN ADULTS (AGE 18 AND OLDER) WITH DIABETES. THE STS-7 SYSTEM IS INTENDED FOR USE BY PATIENTS AT HOME AND IN HEALTH CARE FACILITIES. THE DEVICE IS FOR PRESCRIPTION USE ONLY. THE STS-7 CONTINUOUS GLUCOSE MONITORING SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE STS-7 CONTINUOUS GLUCOSE MONITORING SYSTEM AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF THE STS-7 SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.