Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
Device class 3 · Review panel CV
FDA PMA supplement record
P200002/S009
Cannula with Guide
Supplement S009 to premarket approval P200002. Product code OCM. Decision 28 August 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 | P200002 | pma_number |
| Supplement number | S009 | supplement_number |
| Applicant | AtriCure, Inc. | applicant |
| Trade name | Cannula with Guide | 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 | 2024-05-31 | date_received |
| Decision date | 2024-08-28 | decision_date |
| Decision code | APPR | decision_code |
| Supplement type | Normal 180 Day Track | supplement_type |
| Supplement reason | Labeling Change - Indications/instructions/shelf life/tradename | supplement_reason |
Source: FDA openFDA, device/pma, P200002/S009, 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 |
|---|---|---|---|
| P200002 FDA | original approval | empty | 2021-04-28 |
| P200002/S015 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-09-24 |
| P200002/S014 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2026-05-06 |
| P200002/S013 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2025-11-14 |
| P200002/S012 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2025-10-07 |
| P200002/S011 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-06-17 |
| P200002/S010 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2025-03-03 |
| P200002/S009 FDA | Normal 180 Day Track | Labeling Change - Indications/instructions/shelf life/tradename | 2024-08-28 |
| P200002/S008 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2023-12-11 |
| P200002/S007 FDA | Real-Time Process | Labeling Change - Indications/instructions/shelf life/tradename | 2023-11-22 |
| P200002/S006 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-05-25 |
| P200002/S005 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2023-05-19 |
| P200002/S004 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2022-12-27 |
| P200002/S003 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2022-10-13 |
| P200002/S002 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2022-08-16 |
| P200002/S001 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2022-01-10 |
Source: FDA openFDA, device/pma, records of P200002, retrieved 2026-10-16 02:28 Eastern. 16 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:P200002+AND+supplement_number:S009&limit=1
{
"id": "e8581f9a-38b4-4ba3-a0d0-38a524f8eb24",
"pma_key": "P200002/S009",
"pma_number": "P200002",
"supplement_number": "S009",
"applicant": "AtriCure, Inc.",
"trade_name": "Cannula with Guide",
"generic_name": "Surgical cardiac ablation device, for treatment of atrial fibrillation",
"product_code": "OCM",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2024-08-28",
"decision_code": "APPR",
"supplement_type": "Normal 180 Day Track",
"supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
"date_received": "2024-05-31",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200002&s=S009",
"verified_at": "2026-10-16T06:52:20.579+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": "2026-10-16T06:52:20.579+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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