The following data is part of a premarket notification filed by Ela Medical, Inc. with the FDA for Stela Ut46 And Bt45/46 Straight Tined Pacing Leads, Stela Uj45 And Bj44/45 J-shaped Tined Pacing Leads.
| Device ID | K000029 |
| 510k Number | K000029 |
| Device Name: | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS |
| Classification | Permanent Pacemaker Electrode |
| Applicant | ELA MEDICAL, INC. 2950 XENIUM LN. NORTH Plymouth, MN 55441 |
| Contact | Catherine G Goble |
| Correspondent | Catherine G Goble ELA MEDICAL, INC. 2950 XENIUM LN. NORTH Plymouth, MN 55441 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-05 |
| Decision Date | 2000-04-04 |