The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Polyflex 483-09 Endocardial Implantable Pacinglead.
| Device ID | K854069 |
| 510k Number | K854069 |
| Device Name: | POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE PACINGLEAD |
| Classification | Permanent Pacemaker Electrode |
| Applicant | INTERMEDICS, INC. P.O. BOX 617 Freeport, TX 77541 -0617 |
| Contact | David Makanani |
| Correspondent | David Makanani 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 | 1985-10-04 |
| Decision Date | 1985-12-09 |