| Proprietary Name: | EMBLEM MRI S-ICD Subcutaneous Implantable Cardioverter Defibrillator; EMBLEM S-ICD Electrode; EMBLEM S-ICD Electrode Delivery System; EMBLEM S-ICD Electrode Insertion System; EMBLEM S-ICD Programmer; EMBLEM S-ICD Pulse Generator; EMBLEM S-ICD Subcutaneous Electrode; EMBLEM S-ICD Subcutaneous Implantable Cardioverter Defibrillator; EMBLEM S-ICD System Patient Screen Tool; Log Data Card for the Model 3200 EMBLEM S-ICD Programmer; Power Supply for S-ICD Programmer Tool; SQ-RX Pulse Generator; Wand for SICD Programmer 3200 |
| Classification Name: | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) |
| Product Code: | LWS |
| Device Class: | 3 |
| Registered Establishment Name: | Boston Scientific Corporation |
| Registered Establishment Number: | 2124215 |
| Premarket Submission Number: | P110042 |
| Owner/Operator: | Boston Scientific Corporation |
| Owner/Operator Number: | 9912058 |
| Establishment Operations: | Manufacturer |