Freezor TM Cardiac Cryoablation Catheter

Supplement S101 to premarket approval P020045. Product code LPB. Decision 24 August 2022.

Approval

Each row is one field of the openFDA record. The grey name is the field’s name in openFDA’s documentation.

Field	Value	Field name
PMA number	P020045	pma_number
Supplement number	S101	supplement_number
Applicant	Medtronic Cryocath, LP	applicant
Trade name	Freezor TM Cardiac Cryoablation Catheter	trade_name
Generic name	Cardiac ablation percutaneous catheter	generic_name
Product code	LPB	product_code
Advisory committee	Cardiovascular	advisory_committee_description
Date received	2022-07-25	date_received
Decision date	2022-08-24	decision_date
Decision code	OK30	decision_code
Supplement type	30-Day Notice	supplement_type
Supplement reason	Process Change - Manufacturer/Sterilizer/Packager/Supplier	supplement_reason

Source: FDA openFDA, device/pma, P020045/S101, retrieved 2026-10-16 02:28 Eastern. Public domain (CC0).

Product code

The FDA classification record for the code on this record.

LPB

Cardiac Ablation Percutaneous Catheter

Device class 3 · Review panel CV

All records with this codeClassification record on FDA

ArrHub vocabulary

Electrophysiology

LPB is one of the 61 product codes in ArrHub’s electrophysiology vocabulary, each held with its FDA classification record as its citation. Vocabulary entry verified 20 September 2026.

Supplement history

Every record of this PMA number in ArrHub’s verified view, newest first. Routine notices are listed, never summarised away.

Record	Type	Reason	Decision
P020045 FDA	original approval	empty	2003-04-17
P020045/S113 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2026-04-23
P020045/S112 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2025-03-27
P020045/S110 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2024-11-25
P020045/S111 FDA	Normal 180 Day Track No User Fee	Location Change - Manufacturer/Sterilizer/Packager/Supplier	2024-11-13
P020045/S109 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2024-03-29
P020045/S105 FDA	Normal 180 Day Track	Change Design/Components/Specifications/Material	2024-02-01
P020045/S108 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2024-01-08
P020045/S107 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2023-12-15
P020045/S106 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2023-11-29
P020045/S104 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2023-05-31
P020045/S103 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2023-05-02
P020045/S102 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2023-01-19
P020045/S101 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2022-08-24
P020045/S100 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2022-03-15
P020045/S098 FDA	Normal 180 Day Track No User Fee	Labeling Change - Indications/instructions/shelf life/tradename	2022-02-18
P020045/S095 FDA	Normal 180 Day Track	Change Design/Components/Specifications/Material	2021-10-12
P020045/S097 FDA	Normal 180 Day Track No User Fee	Location Change - Manufacturer/Sterilizer/Packager/Supplier	2021-09-10
P020045/S099 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2021-08-22
P020045/S096 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2021-06-01
P020045/S094 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2021-03-17
P020045/S092 FDA	Normal 180 Day Track	Change Design/Components/Specifications/Material	2020-03-02
P020045/S093 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2020-02-03
P020045/S090 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2019-10-09

Source: FDA openFDA, device/pma, records of P020045, retrieved 2026-10-16 02:28 Eastern. 24 records in the verified view. Each identifier links to the FDA’s page.

ArrHub

What ArrHub adds to the record. Everything above this line is the agency’s; everything here is ArrHub’s, dated and attributed.

Record pair

No confirmed pair across the two registers for this record.

Resolved to

Medtronic

The register name above is resolved to its organisation under ArrHub’s alias table. Method: manual. Source: fda_applicant. Verified 20 September 2026.

Not yet in ArrHub’s weekly snapshot.

Raw record

The stored record exactly as ArrHub holds it, for anyone who wants to check the page against it.

Show the raw record (JSON)device/pma.json?search=pma_number:P020045+AND+supplement_number:S101&limit=1

{
  "id": "3dafcac2-4079-4dcd-a29e-21439c3adc7b",
  "pma_key": "P020045/S101",
  "pma_number": "P020045",
  "supplement_number": "S101",
  "applicant": "Medtronic Cryocath, LP",
  "trade_name": "Freezor TM Cardiac Cryoablation Catheter",
  "generic_name": "Cardiac ablation percutaneous catheter",
  "product_code": "LPB",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2022-08-24",
  "decision_code": "OK30",
  "supplement_type": "30-Day Notice",
  "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
  "date_received": "2022-07-25",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020045&s=S101",
  "verified_at": "2026-10-16T06:48:23.242+00:00",
  "created_at": "2026-10-16T06:28:37.266536+00:00",
  "collected_at": "2026-10-16T06:28:22.358+00:00",
  "last_checked_at": "2026-10-16T06:48:23.242+00:00"
}

The readable page is rendered from the record held in ArrHub’s verified view; the agency record at api.fda.gov governs where they differ.

Links open the agency’s own records. Unlabelled links open web pages. Links marked (JSON) open an agency’s data record, which a browser shows as plain text.

Report a broken link or a record that does not match its source: alerts@arrhub.com. Corrections are published, with their date, at arrhub.com/corrections.