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PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP

FDA premarket approval P980022/S183 · decided 2016-06-03

Approval details

PMA number
P980022
Supplement
S183
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2015-11-03
Decision date
2016-06-03
Days to decision
213 days
Decision code
APPR
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
Approval for changes to the pump case drive support cap assembly process and the automated adhesive dispensing process used in the pump case manufacturing process of the Paradigm family of insulin pumps (models 5xx and 7xx). Paradigm insulin pumps are components of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System and the MiniMed 530G System.

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