| Proprietary Name: |
#2 Bi-directional Torque Wrench; Bifurcated Bipolar Endocardial Tined Lead; Bipolar Endocardial Lead; ECD High Voltage Induction Cable; Large Patch Lead; Lead Anchors; Lead Cap; Lead Cap Kit; Lead Pulling Tip 4.75 / 6.1 mm Tunnel Tip; Lead Pulling Tip, 3.2 mm (IS-1 Tunnel Tip); Lead Repair Kit; Lead Stabilizer Kit; Lead Tunneler; Lead Tunneler Handle; Medical Adhesive; Mineral Oil; Model 1550 AICD Software Module; Myocardial Sutureless Lead; Positive Fixation Protected Helix Bipolar Endocardial Lead; Small Patch Lead; Stylet; Stylet Accessory Kit; Superior Vena Cava Lead; VENTAK; VENTAK P; VENTAK P2; VENTAK P3; Wrench Kit |
| Classification Name: |
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) |
| Product Code: |
LWS |
| Device Class: |
3 |
| Registered Establishment Name: |
Boston Scientific Corporation
|
| Registered Establishment Number: |
2648729
|
| Owner/Operator: |
Boston Scientific Corporation |
| Owner/Operator Number: |
9912058
|
| Establishment Operations: |
Manufacturer
|
