Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
Device class 3 · Review panel CV
FDA PMA supplement record
P230030/S014
FARAPULSE™ Pulsed Field Ablation System
Supplement S014 to premarket approval P230030. Product code QZI. Decision 14 August 2025.
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 | P230030 | pma_number |
| Supplement number | S014 | supplement_number |
| Applicant | Farapulse, Inc. | applicant |
| Trade name | FARAPULSE™ Pulsed Field Ablation System | trade_name |
| Generic name | Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation | generic_name |
| Product code | QZI | product_code |
| Advisory committee | Cardiovascular | advisory_committee_description |
| Date received | 2025-07-09 | date_received |
| Decision date | 2025-08-14 | decision_date |
| Decision code | APPR | decision_code |
| Supplement type | Normal 180 Day Track No User Fee | supplement_type |
| Supplement reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier | supplement_reason |
Source: FDA openFDA, device/pma, P230030/S014, 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
QZI 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 |
|---|---|---|---|
| P230030 FDA | original approval | empty | 2024-01-30 |
| P230030/S025 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-10-02 |
| P230030/S024 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2026-09-04 |
| P230030/S016 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2026-08-25 |
| P230030/S018 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2026-08-06 |
| P230030/S022 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-07-10 |
| P230030/S023 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-06-26 |
| P230030/S021 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-06-05 |
| P230030/S019 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-05-06 |
| P230030/S017 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-01-13 |
| P230030/S012 FDA | Panel Track | Labeling Change - Indications/instructions/shelf life/tradename | 2026-01-12 |
| P230030/S013 FDA | Normal 180 Day Track | Labeling Change - Indications/instructions/shelf life/tradename | 2025-09-24 |
| P230030/S014 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-08-14 |
| P230030/S015 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-08-12 |
| P230030/S007 FDA | Panel Track | Labeling Change - Indications/instructions/shelf life/tradename | 2025-07-03 |
| P230030/S011 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-04-03 |
| P230030/S010 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-03-10 |
| P230030/S009 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-02-18 |
| P230030/S008 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-02-08 |
| P230030/S006 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-10-24 |
| P230030/S003 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2024-10-18 |
| P230030/S005 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-07-05 |
| P230030/S002 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2024-06-18 |
| P230030/S004 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-05-03 |
| P230030/S001 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-03-13 |
Source: FDA openFDA, device/pma, records of P230030, retrieved 2026-10-16 02:28 Eastern. 25 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.
Health Canada record pair
111047Class IV licence, first issued 4 April 2024. Pair confirmed under the verification protocol by product name, human review, 24 September 2026; reference class pfa_system.
65
Days from the FDA decision to the first issued Canadian licence. Computed from the two dates.
Resolved to
Boston Scientific
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:P230030+AND+supplement_number:S014&limit=1
{
"id": "af8e037f-2ce0-4a49-94fc-513128b25669",
"pma_key": "P230030/S014",
"pma_number": "P230030",
"supplement_number": "S014",
"applicant": "Farapulse, Inc.",
"trade_name": "FARAPULSE Pulsed Field Ablation System",
"generic_name": "Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation",
"product_code": "QZI",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2025-08-14",
"decision_code": "APPR",
"supplement_type": "Normal 180 Day Track No User Fee",
"supplement_reason": "Location Change - Manufacturer/Sterilizer/Packager/Supplier",
"date_received": "2025-07-09",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230030&s=S014",
"verified_at": "2026-10-16T06:53:12.437+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": "2026-10-16T06:53:12.437+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.
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