|
Device | MODEL 6960 SWITCHABLE ECG PATIENT CABLE |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S026 |
Date Received | 12/21/1998 |
Decision Date | 01/20/1999 |
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 Approva for a switchable ECG cable that allows the clinician to display and record ECG signals from seven different vectors (leads) without moving the ECG electrodes that are attached to the patient. The device, as modified, will be marketed under the trade name Model 6960 Switchable ECG Cable and is indicated for use as an accessory to the Models 2950 and 2901 Programmer/Recorder/Monitors (PRMs). |