PMA P990026S014
- Device
- GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER
- Applicant
- Animas Corp.
- PMA number
- P990026
- Supplement
- S014
- Product code
- CGA
- Decision date
- 2002-08-23
- Classification
- Clinical Chemistry
- Generic name
- GLUCOSE OXIDASE, GLUCOSE
- Approval order statement
- APPROVAL FOR EXTENSION OF THE SHELF LIFE OF THE AUTOSENSOR FROM 6 MONTHS TO 18 MONTHS.
Current openFDA PMA Record#
- Device
- GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER
- Applicant
- Animas Corp.
- PMA number
- P990026
- Supplement
- S014
- Product code
- CGA
- Generic name
- GLUCOSE OXIDASE, GLUCOSE
- Decision date
- 2002-08-23
- Decision code
- APPR
- Date received
- 2002-08-08
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR EXTENSION OF THE SHELF LIFE OF THE AUTOSENSOR FROM 6 MONTHS TO 18 MONTHS.