GUARDIAN REAL-TIME MONITOR
FDA premarket approval P980022/S027 · decided 2008-06-16
Approval details
- PMA number
- P980022
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GUARDIAN REAL-TIME MONITOR
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2008-05-16
- Decision date
- 2008-06-16
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- CHANGES TO THE MONITOR VIBRATOR MOTOR INCLUDING CONFORMANCE WITH ROHS DIRECTIVE WHICH RESTRICTS THE USE OF HAZARDOUS MATERIALS IN THE MANUFACTURE OF ELECTRICAL AND ELECTRONIC PRODUCTS.
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