The following data is part of a premarket notification filed by Pace Medical with the FDA for Pace Implant. Lead/tined/atrial/j/model 3290.
| Device ID | K864153 |
| 510k Number | K864153 |
| Device Name: | PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | PACE MEDICAL 391 TOTTEN POND RD. Waltham, MA 02451 |
| Contact | Ralph E Hanson |
| Correspondent | Ralph E Hanson PACE MEDICAL 391 TOTTEN POND RD. Waltham, MA 02451 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-23 |
| Decision Date | 1987-01-06 |