|
Device | MINILINK REAL-TIME TRANSMITTER, IPRO2 RECORDER |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S156 |
Date Received | 04/29/2014 |
Decision Date | 10/02/2014 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO REPLACE THE CURRENT HOLDER (BLUE TEST PLUG)USED AS A PRODUCTION AID DURING SUB-ASSEMBLY MANUFACTURING OF THE MINILINK (MMT-7703) ANDIPRO2 (MMT-7741) TRANSMITTERS TO TWO NEW HOLDERS. THE MINILINK TRANSMITTER IS A COMPONENT OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, MINILINKREAL-TIME AND MINIMED 530G SYSTEMS. THE IPRO2 TRANSMITTER IS A COMPONENT OF THE IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM. |