PMA P050012S032
- Device
- DEXCOM SEVEN & SEVEN PLUS SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S032
- Product code
- MDS
- Decision date
- 2010-08-25
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- CHANGE TO THE MANUFACTURE OF THE DEXCOM SEVEN AND SEVEN PLUS SYSTEM RECEIVER TO IMPROVE THE MANUFACTURING CONSISTENCY OF THE RECEIVER COMPONENT OF THE DEVICE.
Current openFDA PMA Record#
- Device
- DEXCOM SEVEN & SEVEN PLUS SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S032
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2010-08-25
- Decision code
- OK30
- Date received
- 2010-08-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE MANUFACTURE OF THE DEXCOM SEVEN AND SEVEN PLUS SYSTEM RECEIVER TO IMPROVE THE MANUFACTURING CONSISTENCY OF THE RECEIVER COMPONENT OF THE DEVICE.