|
Device | ALLURE AND ALLURE QUADRA FAMILY OF CRT-P DEVICES |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P030035 |
Supplement Number | S144 |
Date Received | 12/07/2015 |
Decision Date | 01/04/2016 |
Product Code |
NIK |
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 ALTERNATIVE SUPPLIER FOR THE TELEMETRY COIL COMPONENT OF THE HYBRID ASSEMBLIES. |