Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Device class 3 · Review panel CV
FDA PMA supplement record
P210027/S011
QDOT MICRO Uni-Directional Navigation Catheter
Supplement S011 to premarket approval P210027. Product code OAE. Decision 16 July 2024.
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 | S011 | supplement_number |
| Applicant | Biosense Webster, Inc. | applicant |
| Trade name | QDOT MICRO Uni-Directional Navigation Catheter | 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 | 2024-06-20 | date_received |
| Decision date | 2024-07-16 | 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, P210027/S011, retrieved 2026-10-16 02:28 Eastern. Public domain (CC0).
Product code
The FDA classification record for the code on this record.
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 |
|---|---|---|---|
| P210027 FDA | original approval | empty | 2022-11-23 |
| P210027/S019 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-09-15 |
| P210027/S018 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-09-10 |
| 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 |
| P210027/S012 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2025-04-08 |
| P210027/S014 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-02-26 |
| P210027/S015 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-02-25 |
| P210027/S013 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-11-20 |
| P210027/S008 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-11-15 |
| P210027/S011 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-07-16 |
| P210027/S009 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-05-27 |
| P210027/S005 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-05-22 |
| P210027/S007 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-03-25 |
| P210027/S006 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-03-25 |
| P210027/S004 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2023-09-19 |
| P210027/S002 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2023-07-20 |
| P210027/S003 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-06-12 |
| P210027/S001 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2023-02-24 |
Source: FDA openFDA, device/pma, records of P210027, retrieved 2026-10-16 02:28 Eastern. 19 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.
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:P210027+AND+supplement_number:S011&limit=1
{
"id": "8a32a8cd-44f5-4fc1-a737-f022481abc85",
"pma_key": "P210027/S011",
"pma_number": "P210027",
"supplement_number": "S011",
"applicant": "Biosense Webster, Inc.",
"trade_name": "QDOT MICRO Uni-Directional Navigation Catheter",
"generic_name": "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation",
"product_code": "OAE",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2024-07-16",
"decision_code": "OK30",
"supplement_type": "30-Day Notice",
"supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
"date_received": "2024-06-20",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210027&s=S011",
"verified_at": "2026-10-16T06:52:41.345+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": "2026-10-16T06:52:41.345+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.
© 2026 ArrHub. Content made available under licence.