Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S142 |
Date Received | 04/06/2007 |
Decision Date | 05/07/2007 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE EPIC AND ATLAS FAMILIES OF ICDS AND CRT-DS, INCLUDING: ADDITION OF AN OVER-CURRENT PROTECTION CIRCUIT; ADDED CAPABILITY FOR RAM OPERATION WITH ROM BACKUP WITH DEFIBRILLATION ONLY (DFO) IN THE HARDWARE BACKUP MODE; ADDITION OF DAILY HIGH-VOLTAGE LEAD IMPEDANCE MEASUREMENTS; ADDITION OF LV RING TO RV COIL PACING PULSE CONFIGURATION; ADDITION OF VENTRICULAR INTRINSIC PREFERENCE FEATURE; AND MODIFICATIONS TO PROGRAMMER SOFTWARE AND DISPLAY ENHANCEMENTS. THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES PROMOTE CRT-D DEVICE MODEL NUMBERS 3107-36 AND 3107-30, AND CURRENT DR AND VR ICD DEVICE MODEL NUMBERS 2107-36, 2107-30 AND 1107-36, 1107-30, AND WILL BE SUPPORTED BY THE MODEL 3650 MERLIN PCS WITH MODEL 3330 VERSION 6.0 SOFTWARE. |
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