MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P980022/S083 · decided 2010-10-06
Approval details
- PMA number
- P980022
- Supplement
- S083
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM
- Generic name
- Sensor, glucose, invasive
- Applicant
- Medtronic Minimed
- Date received
- 2010-08-20
- Decision date
- 2010-10-06
- Days to decision
- 47 days
- Decision code
- APPR
- Product code
- MDS
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR MINOR MODIFICATION TO THE DESIGN OF THE PARADIGM REAL-TIME PUMP CASE (MODELS MMT-522, MMT-522K, MMT-523, MMT-523K) TO ALLOW FOR A ¿TWO SHOT¿ MOLDING TECHNOLOGY FOR THE MANUFACTURE OF THE MAIN CASE BY A NEW SUPPLIER.
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| MEDTRONIC MINIMED PARADIGM INSULIN PUMPS (K120206) | Medtronic Minimed | 2012-03-29 |
| POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS (K100432) | Medtronic Minimed | 2010-07-09 |