CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P980022/S006 · decided 2001-01-09
Approval details
- PMA number
- P980022
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONTINUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Medtronic Minimed
- Date received
- 2000-09-21
- Decision date
- 2001-01-09
- Days to decision
- 110 days
- Decision code
- APPR
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR A NEW MANUFACTURING SITE FOR THE MANUFACTURER OF THE EXTERNAL COMPONENTS OF THE DEVICE. THE NEW SITE IS MINIMED, INC., NORTHRIDGE, CALIFORNIA.
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