The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing Lead.
| Device ID | K954719 |
| 510k Number | K954719 |
| Device Name: | INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD |
| Classification | Permanent Pacemaker Electrode |
| Applicant | INTERMEDICS, INC. 4000 TECHNOLOGY DR. Angleton, TX 77515 |
| Contact | Lori Kleinschrodt Holder |
| Correspondent | Lori Kleinschrodt Holder INTERMEDICS, INC. 4000 TECHNOLOGY DR. Angleton, TX 77515 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-13 |
| Decision Date | 1996-02-27 |