| Proprietary Name: |
4-Site Lead Pulling Tip, 4-SITE; 4-SITE Terminal Tool; Bipolar Positive Fixation lead & adapter; combined models 6017 & 4266; ENDOTAK C; ENDOTAK DSP; ENDOTAK ENDURANCE; ENDOTAK ENDURANCE EZ; ENDOTAK ENDURANCE Rx; ENDOTAK RELIANCE; ENDOTAK RELIANCE 4-Site Active; ENDOTAK RELIANCE 4-Site Passive; ENDOTAK RELIANCE G ? Active; ENDOTAK RELIANCE G ? Passive; ENDOTAK RELIANCE G 4-Site Active; ENDOTAK RELIANCE G 4-Site Passive; ENDOTAK RELIANCE S; ENDOTAK RELIANCE S 4-Site Active; ENDOTAK RELIANCE S 4-Site Passive; ENDOTAK RELIANCE SG ? Active; ENDOTAK RELIANCE SG ? Passive; ENDOTAK RELIANCE SG 4-Site Active; ENDOTAK RELIANCE SG 4-Site Passive; ENDOTAK SQ Array; ENDOTAK SQ Array XP; ENDOTAK SQ Patch Lead; Lead Adapter; Lead Cap Accessory Kit; Lead Cap Kit; Lead Tunneler Kit; Lead Tunneling Tip; Stylet |
| 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
|