The following data is part of a premarket notification filed by Ela Medical, Inc. with the FDA for Stela Model Bj44 And Bj45 Pacing Leads.
| Device ID | K963738 |
| 510k Number | K963738 |
| Device Name: | STELA MODEL BJ44 AND BJ45 PACING LEADS |
| Classification | Permanent Pacemaker Electrode |
| Applicant | ELA MEDICAL, INC. 15245 MINNETONKA BLVD. Minnetonka, MN 55345 |
| Contact | Catherine G Goble |
| Correspondent | Catherine G Goble ELA MEDICAL, INC. 15245 MINNETONKA BLVD. Minnetonka, MN 55345 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Se Subject To Traking & Pms (PT) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-17 |
| Decision Date | 1997-05-23 |
| Summary: | summary |