# K972500: Tir/Tij and Polyrox

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Mar 4, 1998 after 244 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 no predicate by number.

## Indications for use
The POLYROX PX and PX-JBP endocardial leads are designed for use with implantable pulse generators which require pacing leads with a bipolar (BP) 3.2 mm IS-1 connector configuration. The leads are indicated for use in any patient for whom single or dual chamber pacemaker therapy is medically indicated. The BIOTRONIK transvenous TIR 60/53 UP/BP and TIJ 53/45 UP/BP leads are indicated for pacing and sensing in the ventricle or atrium, respectively. The leads are designed for use with implantable pulse generators which require pacing leads with an unipolar (UP) or bipolar (BP) IS-1 connector configuration. The leads may be used with single or dual chamber pacing systems.

Source page: https://510kreport.com/device/K972500
Methodology: https://510kreport.com/methodology