The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Models 438-05 And 435-05 Implantable Pacing Lead.
| Device ID | K922972 |
| 510k Number | K922972 |
| Device Name: | MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD |
| Classification | Permanent Pacemaker Electrode |
| Applicant | INTERMEDICS, INC. 4000 TECHNOLOGY DR. Angleton, TX 77515 |
| Contact | Anthony Fonseca |
| Correspondent | Anthony Fonseca INTERMEDICS, INC. 4000 TECHNOLOGY DR. Angleton, TX 77515 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Se - Postmarket Surveillance Required (SESP) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-19 |
| Decision Date | 1993-01-22 |