FDA device listing
Accessory for pacemaker, ICD and CRT-D Screw driver,CPR4,Intensia DR 154,Intensia VR 124,Orchestra Plus…
FDA device listing 1092071576 · MicroPort CRM USA, Inc.
Key facts
| Proprietary names | Accessory for pacemaker, ICD and CRT-D Screw driver,CPR4,Intensia DR 154,Intensia VR 124,Orchestra Plus Programmer,Paradym DR 8550,Paradym RF DR 9550,Paradym RF VR 9250,Paradym VR 8250,PLATINIUM DR 1510,PLATINIUM DR 1540,PLATINIUM VR 1210,PLATINIUM VR 1240,Remote Monitoring Software,Smart Monitor,SmartTouch Programmer Software (SmartView),SMARTVIEW Home Monitor |
|---|---|
| Owner/operator | MicroPort CRM USA, Inc. |
| Owner/operator number | 2182863 |
| Premarket submissions | P980049 |
| Product codes | DXY, LWS, MRM, OSR |
| Device names | DXY - Implantable Pacemaker Pulse-Generator, LWS - Implantable Cardioverter Defibrillator (Non-Crt), MRM - Defibrillator, Implantable, Dual-Chamber, OSR - Pacemaker/Icd/Crt Non-Implanted Components |
| Device class | Class III |
| Classification regulations (21 CFR) | 870.3610, ORCA1.LWS, ORCA1.MRM, ORCA1.OSR |
| Review panels | Cardiovascular |
| Registered establishments | Sorin CRM SAS |
| Establishment registrations | 3008159616 |
| FEI numbers | 3008159616 |
| Establishment operations | Complaint File Establishment, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database