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CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA premarket approval P980022/S190 · decided 2016-04-05

Approval details

PMA number
P980022
Supplement
S190
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2016-03-07
Decision date
2016-04-05
Days to decision
29 days
Decision code
OK30
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
Relocation of a contract manufacturing facility for printed circuit boards and board stack assemblies used in all Medtronic MiniMed Paradigm Real-Time Revel insulin pumps, Paradigm Real-Time insulin pumps, and MiniMed 530G insulin pumps. The firm is also requesting changes in the manufacturing process sequence as well as updates to mechanical drawings to add vendor name and pump models. The Paradigm Real-Time insulin pumps are a component of the Paradigm Real-Time System, Paradigm Real-Time Reve

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