|
Device | PROFILE MD (MODELS V-186F AND V-186HV3), PHOTON DR (MODEL V-230HV) AND PHOTON U VR/DR IMPLANTABLE CARDIOVERTER |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S055 |
Date Received | 09/05/2001 |
Decision Date | 10/02/2001 |
Product Code |
LWS |
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 MODEL 3307 V2.4.1A PROGRAMMER SOFTWARE WHICH ALLOWS FOR THE INTEGRITY AFX DR MODEL 5342 AND INTEGRITY 5 DR MODEL 5336 TO ACCESS THE DYNAMIC ATRIAL OVERDRIVE (DAO) AND ADVANCED HYSTERESIS FEATURES. |