The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Polyflex Implantable Pacing Lead-476-07.
| Device ID | K853521 |
| 510k Number | K853521 |
| Device Name: | POLYFLEX IMPLANTABLE PACING LEAD-476-07 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
| Contact | Lisa S Jones |
| Correspondent | Lisa S Jones INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-22 |
| Decision Date | 1985-12-04 |