Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Device class 3 · Review panel CV
FDA PMA supplement record
P200028/S024
DiamondTemp Ablation System
Supplement S024 to premarket approval P200028. Product code OAE. Decision 6 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 | P200028 | pma_number |
| Supplement number | S024 | supplement_number |
| Applicant | Medtronic, Inc. | applicant |
| Trade name | DiamondTemp Ablation System | 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 | 2024-04-11 | date_received |
| Decision date | 2024-08-06 | 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, P200028/S024, 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 |
|---|---|---|---|
| P200028 FDA | original approval | empty | 2021-01-28 |
| P200028/S026 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2025-10-10 |
| P200028/S024 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2024-08-06 |
| P200028/S023 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-03-08 |
| P200028/S022 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-10-12 |
| P200028/S020 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-07-21 |
| P200028/S021 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-07-19 |
| P200028/S018 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2023-06-21 |
| P200028/S017 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2023-05-24 |
| P200028/S016 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-03-13 |
| P200028/S015 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-03-01 |
| P200028/S013 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2022-12-13 |
| P200028/S014 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2022-11-16 |
| P200028/S012 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2022-10-12 |
| P200028/S011 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-06-15 |
| P200028/S009 FDA | Real-Time Process | Labeling Change - Indications/instructions/shelf life/tradename | 2022-05-02 |
| P200028/S008 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2022-03-17 |
| P200028/S010 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-03-04 |
| P200028/S002 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2021-11-02 |
| P200028/S007 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-10-27 |
| P200028/S005 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2021-06-02 |
| P200028/S004 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2021-05-28 |
| P200028/S003 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2021-05-25 |
| P200028/S006 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2021-05-19 |
| P200028/S001 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-03-08 |
Source: FDA openFDA, device/pma, records of P200028, 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.
Record pair
No confirmed pair across the two registers for this record.
Resolved to
Medtronic
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:P200028+AND+supplement_number:S024&limit=1
{
"id": "753e42bd-686a-4ded-8f26-4394a27ddbdc",
"pma_key": "P200028/S024",
"pma_number": "P200028",
"supplement_number": "S024",
"applicant": "Medtronic, Inc.",
"trade_name": "DiamondTemp Ablation System",
"generic_name": "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation",
"product_code": "OAE",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2024-08-06",
"decision_code": "APPR",
"supplement_type": "Normal 180 Day Track No User Fee",
"supplement_reason": "Postapproval Study Protocol",
"date_received": "2024-04-11",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200028&s=S024",
"verified_at": "2026-10-16T06:52:35.098+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": "2026-10-16T06:52:35.098+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.