The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Leads Utiliz Volun Stand #1 3.2 Mm Uni/biopolar Co.
| Device ID | K861440 |
| 510k Number | K861440 |
| Device Name: | LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO |
| 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 | 1986-04-17 |
| Decision Date | 1986-05-13 |