The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable Endocardial Pacing Lead.
| Device ID | K955122 |
| 510k Number | K955122 |
| Device Name: | INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR 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 | 1995-11-09 |
| Decision Date | 1996-11-04 |
| Summary: | summary |