The following data is part of a premarket notification filed by Edwards Pacemaker Systems with the FDA for Pacemaker, Prolith 23u. Pulse Generator.
| Device ID | K780238 |
| 510k Number | K780238 |
| Device Name: | PACEMAKER, PROLITH 23U. PULSE GENERATOR |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | EDWARDS PACEMAKER SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-13 |
| Decision Date | 1978-03-15 |