QDOT MICRO™ System

Supplement S016 to premarket approval P210027. Product code OAE. Decision 17 April 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	P210027	pma_number
Supplement number	S016	supplement_number
Applicant	Biosense Webster, Inc.	applicant
Trade name	QDOT MICRO™ 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	2026-03-27	date_received
Decision date	2026-04-17	decision_date
Decision code	APPR	decision_code
Supplement type	Special (Immediate Track)	supplement_type
Supplement reason	Labeling Change - Indications/instructions/shelf life/tradename	supplement_reason

Source: FDA openFDA, device/pma, P210027/S016, retrieved 2026-09-19 21:55 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 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
P210027 FDA	original approval	empty	2022-11-23
P210027/S017 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-08-17
P210027/S016 FDA	Special (Immediate Track)	Labeling Change - Indications/instructions/shelf life/tradename	2026-04-17

Source: FDA openFDA, device/pma, records of P210027, retrieved 2026-09-19 21:55 Eastern. 3 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

Johnson & Johnson

The register name above is resolved to its organisation under ArrHub’s alias table. Method: manual:m&a. 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:P210027+AND+supplement_number:S016&limit=1

{
  "id": "70249262-afc1-4bfb-9340-1392400eb548",
  "pma_key": "P210027/S016",
  "pma_number": "P210027",
  "supplement_number": "S016",
  "applicant": "Biosense Webster, Inc.",
  "trade_name": "QDOT MICRO System",
  "generic_name": "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation",
  "product_code": "OAE",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2026-04-17",
  "decision_code": "APPR",
  "supplement_type": "Special (Immediate Track)",
  "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
  "date_received": "2026-03-27",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210027&s=S016",
  "verified_at": "2026-09-20T01:57:15.339+00:00",
  "created_at": "2026-09-20T01:55:37.743665+00:00",
  "collected_at": "2026-09-20T01:55:23.426+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.