The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Programalith Iii 240 Pulse Generator.
| Device ID | K850464 |
| 510k Number | K850464 |
| Device Name: | PROGRAMALITH III 240 PULSE GENERATOR |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar, CA 91342 |
| Contact | Nestor Kushierz |
| Correspondent | Nestor Kushierz 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 | 1985-02-07 |
| Decision Date | 1985-05-15 |