CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P980022/S008 · decided 2002-09-05
Approval details
- PMA number
- P980022
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONTINUOUS GLUCOSE MONITORING SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2002-04-15
- Decision date
- 2002-09-05
- Days to decision
- 143 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE CHANGE AND A DESIGN MODIFICATION OF THE GLUCOSE SENSOR COMPONENT OF THE CONTINUOUS GLUCOSE MONITORING SYSTEM.
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