PMA P050012S015
- Device
- DEXCOM SEVEN SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S015
- Product code
- MDS
- Decision date
- 2008-07-16
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- CHANGE TO EXTEND THE CURING TIME OF THE SENSOR SUB-ASSEMBLY.
Current openFDA PMA Record#
- Device
- DEXCOM SEVEN SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S015
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2008-07-16
- Decision code
- OK30
- Date received
- 2008-06-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO EXTEND THE CURING TIME OF THE SENSOR SUB-ASSEMBLY.