MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD
Device Facts
| Record ID | K851458 |
|---|---|
| Device Name | MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD |
| Applicant | Intermedics, Inc. |
| Product Code | DTD · Cardiovascular |
| Decision Date | Jul 11, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3620 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions.”
