| Device Type ID | 782 |
| Device Name | Pacemaker Lead Adaptor |
| Regulation Description | Pacemaker Lead Adaptor. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Implantable Electrophysical Devices Branch (IEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.3620 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DTD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 782 |
| Device | Pacemaker Lead Adaptor |
| Product Code | DTD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Pacemaker Lead Adaptor. |
| CFR Regulation Number | 870.3620 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
OSCOR INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSCOR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 31 |
Connection Problem | 5 |
High Capture Threshold | 5 |
High Impedance | 4 |
Signal Artifact | 4 |
Over-Sensing | 4 |
Fracture | 4 |
Low Impedance | 3 |
Impedance Problem | 3 |
Ambient Noise Problem | 2 |
Insufficient Information | 2 |
Electrical /Electronic Property Problem | 2 |
Capturing Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Appropriate Term/Code Not Available | 1 |
High Sensing Threshold | 1 |
Electronic Property Issue | 1 |
Material Integrity Problem | 1 |
Pocket Stimulation | 1 |
Failure To Capture | 1 |
Device Operates Differently Than Expected | 1 |
Human-Device Interface Problem | 1 |
Break | 1 |
Mechanical Problem | 1 |
Device Markings / Labelling Problem | 1 |
Pacing Problem | 1 |
Material Deformation | 1 |
| Total Device Problems | 84 |