# K061212: Biotronik Endocardial Pacing Leads

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: Jul 10, 2006 after 70 days
- Product code: DTB (Permanent Pacemaker Electrode)
- Device class: 3
- Regulation: 21 CFR 870.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Arox: named in the summary without a submission number
- (no number) Synox: named in the summary without a submission number
- (no number) Synox with 15 mm tip to ring spacing: named in the summary without a submission number
- (no number) Polyrox w/ 15 mm Spacing: named in the summary without a submission number
- (no number) Polyrox: named in the summary without a submission number
- (no number) YR: named in the summary without a submission number

## Indications for use
BIOTRONIK's endocardial leads are designed for use with implantable pulse generators that require pacing leads with a bipolar IS-1 connector configuration; they may be used with single or dual chamber pacing systems. The leads are designed for use in patients for whom single or dual chamber pulse generator therapy is medically indicated. This indication follows that recommended in the Class I definition of the ACC/AHA/NASPE Task Force Report, entitled "ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee on Pacemaker Implantation)' (Gregoratos et al. 2002). The straight lead models are intended for placement in either the right atrium or right ventricle. The JBP lead models have a pre-formed J-shaped distal end to facilitate lead placement in the right atrial appendage.

Source page: https://510kreport.com/device/K061212
Methodology: https://510kreport.com/methodology