The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Low Profile Lead Connector Modification (4002).
| Device ID | K801284 |
| 510k Number | K801284 |
| Device Name: | LOW PROFILE LEAD CONNECTOR MODIFICATION (4002) |
| Classification | Permanent Pacemaker Electrode |
| Applicant | MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis, MN 55432 -3576 |
| Contact | Keith J Proctor |
| Correspondent | Keith J Proctor MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis, MN 55432 -3576 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-29 |
| Decision Date | 1980-12-01 |