Clearance Summary
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS received FDA 510(k) clearance under submission number K000029, sponsored by Ela Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-04-04.
- Submission: K000029
- Applicant / Sponsor: Ela Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3680
- Decision date: 2000-04-04
Classification & Regulation
This clearance is catalogued under FDA product code DTB and 21 CFR 870.3680, within the Cardiovascular review panel as a Class III device.