The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Prolog Mp Pulse Generators 658k And 658t.
| Device ID | K872779 |
| 510k Number | K872779 |
| Device Name: | PROLOG MP PULSE GENERATORS 658K AND 658T |
| Classification | Implantable Pacemaker Pulse-generator |
| 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 | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-14 |
| Decision Date | 1987-11-04 |