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Chilli Cooled Ablation System

by Boston Scientific

PMA P990054

Chilli Cooled Ablation System is a Class III cardiac ablation percutaneous catheter made by Boston Scientific, approved under FDA PMA P990054 on 17 Mar 2000, withdrawn as of 22 Oct 2026. One FDA recall is linked to it.

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 17 Mar 2000

PMA

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA PMA, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP990054 Date17 Mar 2000Approval withdrawnStatusWithdrawn

Official records

Recalls

1 recall · FDA

    • Terminated Z-0170-2011 FDA Unclassified (pre-2012) initiated 27 Sep 2010

    Boston Scientific is conducting a Recall on CircuCool Tubing Sets used with the Chilli II Cooled Ablation System because there may be a potential for a sterile barrier breach which could compromise device sterility and potentially the sterile field. Even though there have been no reported complaints.

Timeline

2 dated events

  1. Approved FDA PMA P990054
  2. Recall initiated FDA recalls Z-0170-2011

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Withdrawn

Specification

PMA

Generic name
Cardiac ablation percutaneous catheter
FDA applicant
Boston Scientific Corp
PMA number
FDA product code
LPB
Device class
Class III
Advisory committee
Cardiovascular
FDA decision
APWD Approval withdrawn

Similar devices

Other devices filed under FDA product code LPB (Cardiac Ablation Percutaneous Catheter).

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