PMA P130007S009
- Device
- ANIMAS VIBE SYSTEM
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S009
- Product code
- MDS
- Decision date
- 2015-10-21
- Classification
- Sensor, Glucose, Invasive
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- TRANSFERRING THE GLUCOSE ENGINE RADIO FREQUENCY BOARD ASSEMBLY (GE ASSEMBLY) SCREENING TESTING TO THE SUPPLIER. THE GE ASSEMBLY IS A COMPONENT OF THE ANIMAS VIBE SYSTEM.
Current openFDA PMA Record#
- Device
- ANIMAS VIBE SYSTEM
- Applicant
- Animas Corp.
- PMA number
- P130007
- Supplement
- S009
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2015-10-21
- Decision code
- OK30
- Date received
- 2015-09-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- TRANSFERRING THE GLUCOSE ENGINE RADIO FREQUENCY BOARD ASSEMBLY (GE ASSEMBLY) SCREENING TESTING TO THE SUPPLIER. THE GE ASSEMBLY IS A COMPONENT OF THE ANIMAS VIBE SYSTEM.