| 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. |
| |
| Device | CURRENT ICD; EPIC HF/ ATLAS + HF FAMILY OF CRT-DS |
|---|
| Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
|---|
| Applicant | ABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335 |
|---|
| PMA Number | P030054 |
|---|
| Supplement Number | S051 |
|---|
| Date Received | 04/06/2007 |
|---|
| Decision Date | 05/07/2007 |
|---|
| Product Code |
NIK |
| Advisory Committee |
Cardiovascular |
|---|
| Supplement Type | Real-Time Process |
|---|
| Supplement Reason | Change Design/Components/Specifications/Material |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
| Predetermined Change Control Plan Authorized | No |
|---|
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. |
|
|
