The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Lead Body Changes To Hi Perform & Fast-pass Leads.
| Device ID | K861464 |
| 510k Number | K861464 |
| Device Name: | LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS |
| Classification | Permanent Pacemaker Electrode |
| Applicant | PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar, CA 91342 |
| Contact | Rita Brown |
| Correspondent | Rita Brown PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar, CA 91342 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-21 |
| Decision Date | 1986-05-19 |