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 | ALTO SHOCK 4 MODULES |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S019 |
Date Received | 04/13/2005 |
Decision Date | 05/13/2005 |
Product Code |
MRM |
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 CHANGES TO THE MANUFACTURING PROCESS AT INTERNATIONAL RECTIFIER, LEOMINSTER, MASSACHUSETTS AND THALES, NEUILLY-SUR-SEINE, FRANCE. THE MODIFICATIONS INCLUDE: 1) CHANGING THE EPOXY RESIN FOR ENCAPSULATION 2) REMOVING THE PARYLENE COATING 3) CHANGING THE PHOTOCOUPLER AND DISCHARGE CIRCUITS FORM SEPARATE COMPONENTS TO A SINGLE COMPONENT COATED WITH EPOXY 4) CHANGING THE EPOXY FOR ATTACHING THE TRANSFORMER, AND 5) ADDING A SILICONE COVER OVER CERTAIN CAPACITORS PRIOR TO THE FINAL ASSEMBLY PROCESS. |
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