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Freezor™ Xtra 217F5

by Medtronic, Inc.

Freezor™ Xtra 217F5 is a Class III device made by Medtronic, Inc., approved under FDA PMA P020045 on 17 Apr 2003 and listed in FDA GUDID since 11 Apr 2022 (UDI-DI 00763000542115), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

2 closed

Documents

PMA P020045

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00763000542115 UDI-DI Date11 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP020045 Date17 Apr 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P020045 decided 17 Apr 2003 Active
  • FDA GUDID UDI-DI 00763000542115 listed 11 Apr 2022 Listed

Recalls

2 recalls · FDA

    • Terminated Z-2777-2015 FDA Class II initiated 1 Sep 2015

    An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.

    • Terminated Z-1452-06 FDA Unclassified (pre-2012) initiated 4 Aug 2006

    Outer cartons of catheters were mislabeled with two different reference numbers. The front of the package showed the correct reference number; 207F1, however the section on the top of the box incorrectly referenced 207F3. All inside labels (inside the box and affixed on device pouches) showed the correct reference number, 207F1.

Timeline

4 dated events

  1. Approved FDA PMA P020045
  2. Recall initiated FDA recalls Z-1452-06
  3. Recall initiated FDA recalls Z-2777-2015
  4. Listed FDA GUDID 00763000542115

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Freezor™ Xtra
Generic name
Cardiac cryosurgical system catheter
Model / reference
217F5
Primary DI / UDI-DI
00763000542115
PMA number
FDA product code
LPB
GMDN term
Cardiac cryosurgical system catheter
Device class
Class III
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 7.0 French
Catheter Working Length — 108.0 Centimeter

Related devices

Category: Cardiac cryosurgical system catheter

Cleared under the same submission (P020045)

and 8 more cleared under P020045

Similar devices

Other devices filed under FDA product code LPB (Cardiac ablation percutaneous catheter).

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)