Affera Ablation System

Supplement S022 to premarket approval P240013. Product code QZI. Decision 28 May 2026.

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	P240013	pma_number
Supplement number	S022	supplement_number
Applicant	Medtronic, Inc.	applicant
Trade name	Affera Ablation System	trade_name
Generic name	Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation	generic_name
Product code	QZI	product_code
Advisory committee	Cardiovascular	advisory_committee_description
Date received	2026-02-27	date_received
Decision date	2026-05-28	decision_date
Decision code	APPR	decision_code
Supplement type	Real-Time Process	supplement_type
Supplement reason	Labeling Change - Indications/instructions/shelf life/tradename	supplement_reason

Source: FDA openFDA, device/pma, P240013/S022, retrieved 2026-09-19 21:55 Eastern. Public domain (CC0).

Product code

The FDA classification record for the code on this record.

QZI

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

Device class 3 · Review panel CV

All records with this codeClassification record on FDA

ArrHub vocabulary

Electrophysiology

QZI is one of the 56 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
P240013 FDA	original approval	empty	2024-10-24
P240013/S030 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-08-06
P240013/S029 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-08-04
P240013/S026 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2026-07-10
P240013/S022 FDA	Real-Time Process	Labeling Change - Indications/instructions/shelf life/tradename	2026-05-28
P240013/S025 FDA	Normal 180 Day Track No User Fee	Location Change - Manufacturer/Sterilizer/Packager/Supplier	2026-05-15
P240013/S027 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-05-13
P240013/S024 FDA	Special (Immediate Track)	Labeling Change - Indications/instructions/shelf life/tradename	2026-04-21
P240013/S023 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-04-02
P240013/S021 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-03-20
P240013/S020 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-03-06
P240013/S019 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-03-03

Source: FDA openFDA, device/pma, records of P240013, retrieved 2026-09-19 21:55 Eastern. 12 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.

Health Canada record pair

115505

Class IV licence, first issued 3 June 2026. Pair confirmed under the verification protocol by product name, human review, 24 September 2026; reference class pfa_system.

587

Days from the FDA decision to the first issued Canadian licence. Computed from the two dates.

Resolved to

Medtronic

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

First seen by ArrHub’s weekly snapshot: 2026-09-20 08:40 Eastern.

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:P240013+AND+supplement_number:S022&limit=1

{
  "id": "717650b6-55ab-4382-9624-8854b431b7f1",
  "pma_key": "P240013/S022",
  "pma_number": "P240013",
  "supplement_number": "S022",
  "applicant": "Medtronic, Inc.",
  "trade_name": "Affera Ablation System",
  "generic_name": "Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation",
  "product_code": "QZI",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2026-05-28",
  "decision_code": "APPR",
  "supplement_type": "Real-Time Process",
  "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
  "date_received": "2026-02-27",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240013&s=S022",
  "verified_at": "2026-09-20T02:04:57.205+00:00",
  "created_at": "2026-09-20T01:55:41.466163+00:00",
  "collected_at": "2026-09-20T01:55:27.157+00:00",
  "last_checked_at": null
}

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.

Contains information licensed under the Open Government Licence – Canada.

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.

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