Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR SOFTWARE MODEL 9995 |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S294 |
Date Received | 09/26/2012 |
Decision Date | 02/08/2013 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITIONAL IN-PROCESS INSPECTION OF THE HYBRID CATHODE MIX RATIO, NEW PRESSURE TEST EQUIPMENT, NEW MANUFACTURING LINES IN AN EXTENDED CONTROLLED ENVIRONMENT AREA,CMOS PROCESS FLOW CHANGES, AN UPDATE TO TEST SOFTWARE AND HARDWARE FOR INTEGRATED CIRCUITS, THE IMPLEMENTATION OF FACTORYWORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1, ANDUPDATES TO THE IC WAFER PROBE TEST SPECIFICATIONS AND TEST SOFTWARE. |
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