|
Device | ST. JUDE MEDICAL EPIC II/EPIC II + AND ATLAS II/ATLAS II + ICDS AND CRT-D SYSTEMS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S126 |
Date Received | 11/21/2006 |
Decision Date | 12/13/2006 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE ICD/CRT-D DEVICE HYBRID: 1) ADDITION OF A NEW C64 MICRO CONTROLLER INTEGRATED CIRCUIT (IC); 2) CHANGES TO THE C46 VSS SUPPLY CAPACITOR FROM 3.3 UF TO 33 UF; AND 3) CHANGES TO DIODES D17, D19 AND D23 IN THE PROTECTION CIRCUIT. |