| Proprietary Name: |
Accessory kit; Antenna Accessory; Bifurcated Bipolar Endocardial Tined Lead; DF-1 Plug; Large Patch Lead; LATITUDE Communicator Inductive; LATITUDE Communicator RF; LATITUDE G2 Communicator; LATITUDE WAVE Communicator; Multiple Application Utility (MAU); Programmer Recorder Monitor (PRM) System Zoom; Small Patch Lead; Software Disk for the VENTAK MINI Pulse Generators; Software Disk for the VENTAK PRx II / III Pulse Generators; Software Disk for the VENTAK PRx Pulse Generators; VENTAK MINI; VENTAK MINI HE; VENTAK MINI II; VENTAK MINI III; VENTAK MINI III HE; VENTAK MINI IV; VENTAK PRx II; VENTAK PRx III; ZOOM LATITUDE Programmer/Recorder/Monitor |
| Classification Name: |
PROGRAMMER, PACEMAKER |
| Product Code: |
KRG |
| Device Class: |
3 |
| Regulation Number: |
870.3700 |
| Medical Specialty: |
Cardiovascular |
| Registered Establishment Name: |
Boston Scientific Corporation
|
| Registered Establishment Number: |
2124215
|
| Owner/Operator: |
Boston Scientific Corporation |
| Owner/Operator Number: |
9912058
|
| Establishment Operations: |
Manufacturer
|