← Product Code [KFJ](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KFJ) · K813518

# IMPLANT AID SPLICING CRIMP & SLEEVE (K813518)

_Intermedics, Inc. · KFJ · Jan 12, 1982 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KFJ/K813518

## Device Facts

- **Applicant:** Intermedics, Inc.
- **Product Code:** [KFJ](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KFJ.md)
- **Decision Date:** Jan 12, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.3710
- **Device Class:** Class 3
- **Review Panel:** Cardiovascular

## Regulatory Identification

A pacemaker repair or replacement material is an adhesive, a sealant, a screw, a crimp, or any other material used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker pulse generator.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KFJ/K813518](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KFJ/K813518)

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