Aurora EV ICD DVEA3E4

Supplement S069 to premarket approval P220012. Product code LWS. Decision 25 June 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	P220012	pma_number
Supplement number	S069	supplement_number
Applicant	Medtronic, Inc.	applicant
Trade name	Aurora EV ICD DVEA3E4	trade_name
Generic name	Implantable cardioverter defibrillator (non-CRT)	generic_name
Product code	LWS	product_code
Advisory committee	Cardiovascular	advisory_committee_description
Date received	2026-03-30	date_received
Decision date	2026-06-25	decision_date
Decision code	APPR	decision_code
Supplement type	Real-Time Process	supplement_type
Supplement reason	Change Design/Components/Specifications/Material	supplement_reason

Source: FDA openFDA, device/pma, P220012/S069, retrieved 2026-09-19 21:55 Eastern. Public domain (CC0).

Product code

The FDA classification record for the code on this record.

LWS

Implantable Cardioverter Defibrillator (Non-Crt)

Device class 3 · Review panel CV

All records with this codeClassification record on FDA

ArrHub vocabulary

Electrophysiology

LWS 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
P220012 FDA	original approval	empty	2023-10-20
P220012/S075 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-31
P220012/S074 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-31
P220012/S073 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-16
P220012/S069 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2026-06-25
P220012/S072 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-04-30
P220012/S071 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-04-28
P220012/S070 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-04-15
P220012/S068 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-03-06
P220012/S067 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-02-12
P220012/S065 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-02-11
P220012/S066 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-02-10
P220012/S064 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-01-23
P220012/S063 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-01-05

Source: FDA openFDA, device/pma, records of P220012, retrieved 2026-09-19 21:55 Eastern. 14 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: 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:P220012+AND+supplement_number:S069&limit=1

{
  "id": "be30b7a7-5ba5-47d3-8d01-9ad392106c9a",
  "pma_key": "P220012/S069",
  "pma_number": "P220012",
  "supplement_number": "S069",
  "applicant": "Medtronic, Inc.",
  "trade_name": "Aurora EV ICD DVEA3E4",
  "generic_name": "Implantable cardioverter defibrillator (non-CRT)",
  "product_code": "LWS",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2026-06-25",
  "decision_code": "APPR",
  "supplement_type": "Real-Time Process",
  "supplement_reason": "Change Design/Components/Specifications/Material",
  "date_received": "2026-03-30",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220012&s=S069",
  "verified_at": "2026-09-20T01:57:19.339+00:00",
  "created_at": "2026-09-20T01:55:45.395466+00:00",
  "collected_at": "2026-09-20T01:55:31.069+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.

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.