HeartLight System

Supplement S009 to premarket approval P150026. Product code OAE. Decision 16 January 2020.

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	P150026	pma_number
Supplement number	S009	supplement_number
Applicant	Cardiofocus, Inc.	applicant
Trade name	HeartLight System	trade_name
Generic name	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	generic_name
Product code	OAE	product_code
Advisory committee	Cardiovascular	advisory_committee_description
Date received	2019-12-18	date_received
Decision date	2020-01-16	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, P150026/S009, retrieved 2026-10-16 02:28 Eastern. Public domain (CC0).

Product code

The FDA classification record for the code on this record.

OAE

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

Device class 3 · Review panel CV

All records with this codeClassification record on FDA

ArrHub vocabulary

Electrophysiology

OAE 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
P150026/S015 FDA	Normal 180 Day Track No User Fee	Location Change - Manufacturer/Sterilizer/Packager/Supplier	2023-08-11
P150026/S014 FDA	Normal 180 Day Track	Change Design/Components/Specifications/Material	2023-02-24
P150026/S013 FDA	Normal 180 Day Track	Location Change - Manufacturer/Sterilizer/Packager/Supplier	2022-04-02
P150026/S012 FDA	Normal 180 Day Track	Change Design/Components/Specifications/Material	2021-04-06
P150026/S011 FDA	Normal 180 Day Track No User Fee	Postapproval Study Protocol	2020-07-01
P150026/S008 FDA	Normal 180 Day Track	Change Design/Components/Specifications/Material	2020-05-08
P150026/S010 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2020-02-20
P150026/S009 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2020-01-16
P150026/S007 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2019-11-08
P150026/S006 FDA	Special (Immediate Track)	Labeling Change - Indications/instructions/shelf life/tradename	2019-06-24
P150026/S005 FDA	Normal 180 Day Track	Change Design/Components/Specifications/Material	2019-04-08

Source: FDA openFDA, device/pma, records of P150026, retrieved 2026-10-16 02:28 Eastern. 11 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.

Resolution

No verified alias in ArrHub’s table; the name stands as the register spells it.

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:P150026+AND+supplement_number:S009&limit=1

{
  "id": "8cfe50a1-9b01-4828-8107-fda6e67d06c5",
  "pma_key": "P150026/S009",
  "pma_number": "P150026",
  "supplement_number": "S009",
  "applicant": "Cardiofocus, Inc.",
  "trade_name": "HeartLight System",
  "generic_name": "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation",
  "product_code": "OAE",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2020-01-16",
  "decision_code": "OK30",
  "supplement_type": "30-Day Notice",
  "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
  "date_received": "2019-12-18",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150026&s=S009",
  "verified_at": "2026-10-16T06:52:12.862+00:00",
  "created_at": "2026-10-16T06:28:37.103881+00:00",
  "collected_at": "2026-10-16T06:28:22.358+00:00",
  "last_checked_at": "2026-10-16T06:52:12.862+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.

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