← Product Code [DTB](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTB) · K000763

# PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 (K000763)

_Biotronik, GmbH & Co. · DTB · Apr 6, 2000 · Cardiovascular · ST_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTB/K000763

## Device Facts

- **Applicant:** Biotronik, GmbH & Co.
- **Product Code:** [DTB](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTB.md)
- **Decision Date:** Apr 6, 2000
- **Decision:** ST
- **Submission Type:** Special
- **Regulation:** 21 CFR 870.3680
- **Device Class:** Class 3
- **Review Panel:** Cardiovascular

## Regulatory Identification

Temporary pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. Permanent pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTB/K000763](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTB/K000763)

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