The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Vivalith Ii 301 Pulse Generator.
| Device ID | K844334 |
| 510k Number | K844334 |
| Device Name: | VIVALITH II 301 PULSE GENERATOR |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar, CA 91342 |
| Contact | Nes Kusnierz |
| Correspondent | Nes Kusnierz PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar, CA 91342 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-07 |
| Decision Date | 1985-01-10 |