Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Device class 3 · Review panel CV
FDA PMA supplement record
P060019/S044
Therapy Cool Path, Safire BLU, Safire BLU SP, Therapy Cool Path SP, 1500T9-CP RF Generators
Supplement S044 to premarket approval P060019. Product code OAD. Decision 10 January 2019.
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 | P060019 | pma_number |
| Supplement number | S044 | supplement_number |
| Applicant | Irvine Biomedical, Inc. | applicant |
| Trade name | Therapy Cool Path, Safire BLU, Safire BLU SP, Therapy Cool Path SP, 1500T9-CP RF Generators | trade_name |
| Generic name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | generic_name |
| Product code | OAD | product_code |
| Advisory committee | Cardiovascular | advisory_committee_description |
| Date received | 2018-12-12 | date_received |
| Decision date | 2019-01-10 | 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, P060019/S044, 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
OAD 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 |
|---|---|---|---|
| P060019 FDA | original approval | empty | 2007-03-16 |
| P060019/S059 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2026-08-07 |
| P060019/S058 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-12-19 |
| P060019/S057 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-05-28 |
| P060019/S056 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2024-05-22 |
| P060019/S055 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2023-11-29 |
| P060019/S054 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-10-14 |
| P060019/S053 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-05-18 |
| P060019/S052 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-05-04 |
| P060019/S051 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-03-24 |
| P060019/S050 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2021-03-12 |
| P060019/S048 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2020-11-02 |
| P060019/S049 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-10-16 |
| P060019/S047 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2020-04-24 |
| P060019/S046 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-03-04 |
| P060019/S043 FDA | 135 Review Track For 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-08-16 |
| P060019/S045 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-04-11 |
| P060019/S044 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2019-01-10 |
Source: FDA openFDA, device/pma, records of P060019, retrieved 2026-10-16 02:28 Eastern. 18 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
Abbott
The register name above is resolved to its organisation under ArrHub’s alias table. Method: manual. 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:P060019+AND+supplement_number:S044&limit=1
{
"id": "95d2c9a6-c72c-443d-b1ec-a72c141c7cad",
"pma_key": "P060019/S044",
"pma_number": "P060019",
"supplement_number": "S044",
"applicant": "Irvine Biomedical, Inc.",
"trade_name": "Therapy Cool Path, Safire BLU, Safire BLU SP, Therapy Cool Path SP, 1500T9-CP RF Generators",
"generic_name": "catheter, percutaneous, cardiac ablation, for treatment of atrial flutter",
"product_code": "OAD",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2019-01-10",
"decision_code": "APPR",
"supplement_type": "Special (Immediate Track)",
"supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
"date_received": "2018-12-12",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060019&s=S044",
"verified_at": "2026-10-16T06:49:37.179+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": "2026-10-16T06:49:37.179+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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