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MINILINK REAL-TIME TRASMITTER, IPRO2 DIGITAL RECORDER

FDA premarket approval P980022/S164 · decided 2014-12-04

Approval details

PMA number
P980022
Supplement
S164
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
MINILINK REAL-TIME TRASMITTER, IPRO2 DIGITAL RECORDER
Generic name
Sensor, glucose, invasive
Applicant
Medtronic Minimed
Date received
2014-10-21
Decision date
2014-12-04
Days to decision
44 days
Decision code
OK30
Product code
MDS
Advisory committee
Clinical Chemistry
Expedited review
No
Location
Northridge, CA
Statement
IMPLEMENTATION OF FIVE ADDITIONAL PIECES OF EQUIPMENT AT A CONTRACT MANUFACTURER TO SUPPORT THE MANUFACTURE OF THE LITHIUM POLYMER BATTERIES FOR THE MINILINKREAL-TIME TRANSMITTER MODEL NUMBER MMT-7703 AND THE IPRO2 DIGITAL RECORDER MODEL NUMBER MMT-7741. THE MINILINK TRANSMITTER IS A COMPONENT OF THE PARADIGM REAL?] TIME SYSTEM, PARADIGM REAL?] TIME REVEL SYSTEM, GUARDIAN REAL?]TIME SYSTEM, MINILINKREAL?]TIME SYSTEM, AS WELL AS THE MINIMED 530G SYSTEM. THE IPRO2 RECORDER IS A COMPONENT OF THE IP

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