Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
Device class 3 · Review panel CV
FDA PMA supplement record
P100046/S016
Multifunctional Ablation Generator (MAG)
Supplement S016 to premarket approval P100046. Product code OCM. Decision 19 May 2023.
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 | P100046 | pma_number |
| Supplement number | S016 | supplement_number |
| Applicant | AtriCure, Inc. | applicant |
| Trade name | Multifunctional Ablation Generator (MAG) | trade_name |
| Generic name | Surgical cardiac ablation device, for treatment of atrial fibrillation | generic_name |
| Product code | OCM | product_code |
| Advisory committee | Cardiovascular | advisory_committee_description |
| Date received | 2023-04-21 | date_received |
| Decision date | 2023-05-19 | 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, P100046/S016, 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
OCM 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 |
|---|---|---|---|
| P100046 FDA | original approval | empty | 2011-12-14 |
| P100046/S021 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-09-24 |
| P100046/S020 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2026-05-06 |
| P100046/S019 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-06-17 |
| P100046/S018 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2024-03-15 |
| P100046/S017 FDA | Real-Time Process | Labeling Change - Indications/instructions/shelf life/tradename | 2023-11-22 |
| P100046/S016 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2023-05-19 |
| P100046/S015 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-03-23 |
| P100046/S013 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2022-11-15 |
| P100046/S011 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2020-11-20 |
| P100046/S012 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-08-14 |
| P100046/S010 FDA | Normal 180 Day Track No User Fee | Labeling Change - Indications/instructions/shelf life/tradename | 2019-06-26 |
Source: FDA openFDA, device/pma, records of P100046, retrieved 2026-10-16 02:28 Eastern. 12 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
AtriCure
The register name above is resolved to its organisation under ArrHub’s alias table. Method: rule:normalize. 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:P100046+AND+supplement_number:S016&limit=1
{
"id": "a1c06293-f7c4-4e71-8043-dd484c3e0551",
"pma_key": "P100046/S016",
"pma_number": "P100046",
"supplement_number": "S016",
"applicant": "AtriCure, Inc.",
"trade_name": "Multifunctional Ablation Generator (MAG)",
"generic_name": "Surgical cardiac ablation device, for treatment of atrial fibrillation",
"product_code": "OCM",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2023-05-19",
"decision_code": "APPR",
"supplement_type": "Special (Immediate Track)",
"supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
"date_received": "2023-04-21",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100046&s=S016",
"verified_at": "2026-10-16T06:50:43.966+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": "2026-10-16T06:50:43.966+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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