|
Device | INTEGRITY AFX DR MODEL 5346 |
Generic Name | implantable pacemaker Pulse-generator |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S085 |
Date Received | 09/05/2001 |
Decision Date | 10/02/2001 |
Product Codes |
DTB DXY KRG |
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 U DR MODEL 5336 TO ACCESS THE DYNAMIC ATRIAL OVERDRIVE (DAO) AND ADVANCED HYSTERESIS FEATURES. |