PMA P050012S034
- Device
- DEXCOM SEVEN & SEVEN PLUS SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S034
- Product code
- MDS
- Decision date
- 2010-12-10
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- MODIFICATIONS TO IMPLEMENT DATA LOGGER IMPROVEMENTS TO THE EIGHT-CHANNEL CALCHECK SYSTEM.
Current openFDA PMA Record#
- Device
- DEXCOM SEVEN & SEVEN PLUS SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S034
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2010-12-10
- Decision code
- OK30
- Date received
- 2010-11-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATIONS TO IMPLEMENT DATA LOGGER IMPROVEMENTS TO THE EIGHT-CHANNEL CALCHECK SYSTEM.