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Telectronics Pasar Model 4171 PG

by Telectronics, Inc.

PMA P850027

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P850027↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP850027 Date30 Sep 1986ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
PMA Number
FDA Product Code
LWW
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Telectronics Pasar Model 4171 PG is a pulse-generator, single chamber, single, as defined by its generic name and device classification. It is an implantable medical device designed to generate electrical pulses for cardiac rhythm management.

This device was manufactured by Telectronics, Inc. in Englewood, Colorado, and received FDA Premarket Approval (PMA) under application P850027 on September 30, 1986. It is a Class III device identified by product code LWW and was subject to cardiovascular advisory committee review.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What type of device is the Telectronics Pasar Model 4171 PG?

    The Telectronics Pasar Model 4171 PG is a pulse-generator, single chamber, single, as specified in its generic name and confirmed by the openfda device_name field. It is classified as a Class III medical device under product code LWW.

  • Who manufactured the Telectronics Pasar Model 4171 PG and where were they located?

    The device was manufactured by Telectronics, Inc., located at 7400 S. Tucson Way, Englewood, CO 80112, as stated in the applicant and address fields of the device data.

  • When did the Telectronics Pasar Model 4171 PG receive regulatory approval?

    The device received FDA Premarket Approval (PMA) on September 30, 1986, with decision code APPR and PMA number P850027, following receipt of the application on May 6, 1985.