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PARADIGM REAL-TIME INSULIN PUMPS, PARADIGM REAL-TIME REVEL INSULIN PUMPS

FDA premarket approval P980022/S180 · decided 2015-04-16

Approval details

PMA number
P980022
Supplement
S180
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
PARADIGM REAL-TIME INSULIN PUMPS, PARADIGM REAL-TIME REVEL INSULIN PUMPS
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2015-03-18
Decision date
2015-04-16
Days to decision
29 days
Decision code
OK30
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
TRANSFER OF PURCHASING, RECEIVING, AND INCOMING INSPECTION ACTIVITIES OFCERTAIN EXTERNAL INSULIN PUMP COMPONENTS USED IN THE MANUFACTURE OF THE PARADIGM REAL-TIMEPUMP SERIES AND THE MINIMED 530G SERIES FROM THE MEDTRONIC MINIMED NORTHRIDGE FACILITY TO THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY AND FEDEX/3PL FACILITIES IN PUERTO RICO. THE PARADIGM REAL?]TIME FAMILY OF INSULIN PUMPS AND THE MINIMED 530G INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL-TIME/REAL-TIME REVEL SYSTEMS AND THE MINIMED

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510(k) clearances by this applicant

RecordFirmDate
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MiniMed Quick-serter (K160860)Medtronic Minimed2016-09-22
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS (K120206)Medtronic Minimed2012-03-29
POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS (K100432)Medtronic Minimed2010-07-09