The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Intermedics Polyflex Pacing Lead #480-01.
| Device ID | K820267 |
| 510k Number | K820267 |
| Device Name: | INTERMEDICS POLYFLEX PACING LEAD #480-01 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | INTERMEDICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-02 |
| Decision Date | 1985-04-03 |