|
Device | PARADIGM REAL-TIME INSULIN PUMP |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S132 |
Date Received | 02/06/2013 |
Decision Date | 03/01/2013 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement UPDATE TO THE DRIVE SUPPORT DISK DISPENSING PROCESS AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY FOR THE PARADIGM MMT-7XX SERIES. |