PMA P050012S006
- Device
- DEXCOM STS SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S006
- Product code
- MDS
- Decision date
- 2007-01-23
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- REVISED FINAL RELEASE MANUFACTURING SOFTWARE AND TEST PROCEDURE TO IMPROVE PROCESS CONTROLS, AND PROPOSED FINAL RELEASE CRITERIA MODIFICATION FOR THE STS SENSOR.
Current openFDA PMA Record#
- Device
- DEXCOM STS SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S006
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2007-01-23
- Decision code
- OK30
- Date received
- 2007-01-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REVISED FINAL RELEASE MANUFACTURING SOFTWARE AND TEST PROCEDURE TO IMPROVE PROCESS CONTROLS, AND PROPOSED FINAL RELEASE CRITERIA MODIFICATION FOR THE STS SENSOR.