Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Device class 3 · Review panel CV
FDA PMA supplement record
P220032/S006
POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories
Supplement S006 to premarket approval P220032. Product code OAE. Decision 5 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 | P220032 | pma_number |
| Supplement number | S006 | supplement_number |
| Applicant | Boston Scientific Corporation | applicant |
| Trade name | POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories | 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 | 2024-06-05 | date_received |
| Decision date | 2024-07-05 | decision_date |
| Decision code | APPR | decision_code |
| Supplement type | Normal 180 Day Track No User Fee | supplement_type |
| Supplement reason | Postapproval Study Protocol | supplement_reason |
Source: FDA openFDA, device/pma, P220032/S006, 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 |
|---|---|---|---|
| P220032 FDA | original approval | empty | 2023-08-08 |
| P220032/S012 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2026-05-29 |
| P220032/S011 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-08-14 |
| P220032/S010 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2025-03-21 |
| P220032/S009 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-02-10 |
| P220032/S004 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-10-18 |
| P220032/S008 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-09-12 |
| P220032/S007 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-08-23 |
| P220032/S005 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2024-07-30 |
| P220032/S006 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2024-07-05 |
| P220032/S003 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-03-18 |
| P220032/S002 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-12-12 |
| P220032/S001 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2023-11-17 |
Source: FDA openFDA, device/pma, records of P220032, retrieved 2026-10-16 02:28 Eastern. 13 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:P220032+AND+supplement_number:S006&limit=1
{
"id": "ddfdf2f4-349b-4b09-8b74-e6924ce6e8e6",
"pma_key": "P220032/S006",
"pma_number": "P220032",
"supplement_number": "S006",
"applicant": "Boston Scientific Corporation",
"trade_name": "POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories",
"generic_name": "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation",
"product_code": "OAE",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2024-07-05",
"decision_code": "APPR",
"supplement_type": "Normal 180 Day Track No User Fee",
"supplement_reason": "Postapproval Study Protocol",
"date_received": "2024-06-05",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220032&s=S006",
"verified_at": "2026-10-16T06:52:57.529+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": "2026-10-16T06:52:57.529+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.