The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Programalith Iii Models 238 & 239.
| Device ID | K854195 |
| 510k Number | K854195 |
| Device Name: | PROGRAMALITH III MODELS 238 & 239 |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar, CA 91342 |
| Contact | Anita Powe |
| Correspondent | Anita Powe 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 | 1985-10-15 |
| Decision Date | 1986-01-07 |