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Device | ALTO 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S016 |
Date Received | 08/18/2004 |
Decision Date | 11/17/2004 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
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 CHANGES TO THE ALTO 2 ICD LOW-POWER MODULE AND FINAL DEVICE ASSEMBLY PROCESS PERFORMED AT ELA MEDICAL, S.A. |