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PARADIGM REAL TIME INSULIN PUMP, PARADIGN REAL TIME REVEL INSULIN PUMP

FDA premarket approval P980022/S137 · decided 2013-09-24

Approval details

PMA number
P980022
Supplement
S137
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
PARADIGM REAL TIME INSULIN PUMP, PARADIGN REAL TIME REVEL INSULIN PUMP
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2013-08-27
Decision date
2013-09-24
Days to decision
28 days
Decision code
OK30
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
ADDITION OF AN ALTERNATE FACILITY WAREHOUSE SPACE FOR THE HANDLING OF RAW MATERIALS INCLUDING SUBASSEMBLIES AND COMPONENTS FOR THE PARADIGM REAL-TIME INSULIN PUMPS (MMT-522, MMT-522K, MMT-722, MMT-722K) AND PARADIGM REAL-TIME REVEL INSULIN PUMPS (MMT-523, MMT-523K, MMT-723, MMT-723K). THE PARADIGM REAL-TIME INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME SYSTEM AND THE PARADIGM REAL-TIME REVEL INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME REVEL SYSTEM.

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