PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS
Device Facts
| Record ID | K013339 |
|---|---|
| Device Name | PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS |
| Applicant | Oscor, Inc. |
| Product Code | DTB · Cardiovascular |
| Decision Date | Nov 8, 2001 |
| Decision | ST |
| Submission Type | Special |
| Regulation | 21 CFR 870.3680 |
| Device Class | Class 3 |
Regulatory Classification
Identification
Temporary pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. Permanent pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.
