The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Model 430-07 Endocardial Pacing Lead.
| Device ID | K954610 |
| 510k Number | K954610 |
| Device Name: | MODEL 430-07 ENDOCARDIAL PACING LEAD |
| Classification | Permanent Pacemaker Electrode |
| Applicant | INTERMEDICS, INC. 4000 TECHNOLOGY DR. Angleton, TX 77515 |
| Contact | Alan D Totah |
| Correspondent | Alan D Totah INTERMEDICS, INC. 4000 TECHNOLOGY DR. Angleton, TX 77515 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Se Subject To Traking & Pms (PT) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-04 |
| Decision Date | 1996-12-16 |
| Summary: | summary |