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 | Y ADAPTOR /EXTENDER KIT, DF-1 CONNECTOR PORT PIN PLUG, IS-1 CONNECTOR PORT PIN PLUG KIT, LEAD ADAPTOR, SPRINT QUATTRO |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P920015 |
Supplement Number | S100 |
Date Received | 11/21/2012 |
Decision Date | 12/20/2012 |
Product Code |
LWS |
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 IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS. |
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