|
Device | AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILIES OF PACEMAKERS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S146 |
Date Received | 04/24/2007 |
Decision Date | 05/09/2007 |
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 ZEPHYR XL SR MODEL 5626 PACEMAKER WHICH UTILIZES THE XL BATTERY MODEL 9438 WHICH IS CURRENTLY APPROVED FOR USE WITH THE MARKETED ZEPHYR XL DR 5826 PACEMAKER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZEPHYR XL SR MODEL 5626 AND IS INDICATED FOR SINGLE CHAMBER RATE ADAPTIVE PACING. |