Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Device class 3 · Review panel CV
FDA PMA supplement record
P130026/S079
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
Supplement S079 to premarket approval P130026. Product code OAE. Decision 31 August 2022.
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 | P130026 | pma_number |
| Supplement number | S079 | supplement_number |
| Applicant | St Jude Medical | applicant |
| Trade name | TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ | 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 | 2022-08-01 | date_received |
| Decision date | 2022-08-31 | decision_date |
| Decision code | OK30 | decision_code |
| Supplement type | 30-Day Notice | supplement_type |
| Supplement reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier | supplement_reason |
Source: FDA openFDA, device/pma, P130026/S079, 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 |
|---|---|---|---|
| P130026 FDA | original approval | empty | 2014-10-24 |
| P130026/S102 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2026-08-07 |
| P130026/S100 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-06-05 |
| P130026/S101 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-05-29 |
| P130026/S099 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-05-15 |
| P130026/S098 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-01-15 |
| P130026/S097 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-01-08 |
| P130026/S096 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2025-12-23 |
| P130026/S094 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2025-06-20 |
| P130026/S095 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-05-06 |
| P130026/S093 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-04-10 |
| P130026/S092 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-11-27 |
| P130026/S091 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-11-22 |
| P130026/S090 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2024-10-09 |
| P130026/S089 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-07-21 |
| P130026/S086 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2023-11-29 |
| P130026/S088 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-10-26 |
| P130026/S087 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-08-17 |
| P130026/S084 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2023-06-29 |
| P130026/S085 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-05-02 |
| P130026/S083 FDA | Real-Time Process | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-04-17 |
| P130026/S082 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-12-15 |
| P130026/S081 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-12-08 |
| P130026/S080 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-10-28 |
| P130026/S079 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-08-31 |
| P130026/S077 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2022-08-17 |
| P130026/S078 FDA | Real-Time Process | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-04-27 |
| P130026/S072 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2022-03-04 |
| P130026/S070 FDA | Panel Track | Labeling Change - Indications/instructions/shelf life/tradename | 2021-11-04 |
| P130026/S076 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-10-14 |
| P130026/S075 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-09-22 |
| P130026/S069 FDA | Normal 180 Day Track No User Fee | Labeling Change - PAS | 2021-08-03 |
| P130026/S074 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-06-25 |
| P130026/S073 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-05-21 |
| P130026/S071 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-05-18 |
| P130026/S068 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2021-03-12 |
| P130026/S066 FDA | Real-Time Process | Labeling Change - Indications/instructions/shelf life/tradename | 2021-01-10 |
| P130026/S063 FDA | 135 Review Track For 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-01-10 |
| P130026/S067 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-12-18 |
| P130026/S062 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2020-11-02 |
| P130026/S065 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-10-16 |
| P130026/S064 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-08-25 |
| P130026/S058 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2020-06-05 |
| P130026/S061 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-06-04 |
| P130026/S060 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-05-28 |
| P130026/S059 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-04-16 |
| P130026/S056 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-04-06 |
| P130026/S057 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-03-27 |
| P130026/S055 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-01-14 |
| P130026/S054 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-12-16 |
| P130026/S052 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-10-25 |
| P130026/S053 FDA | Special (Immediate Track) | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-10-22 |
| P130026/S051 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2019-10-09 |
| P130026/S050 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-09-18 |
| P130026/S048 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-08-22 |
| P130026/S049 FDA | Special (Immediate Track) | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-07-24 |
| P130026/S047 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-06-19 |
| P130026/S046 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2019-06-13 |
| P130026/S045 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-05-07 |
| P130026/S044 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-04-23 |
| P130026/S043 FDA | Special (Immediate Track) | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-04-10 |
| P130026/S040 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-03-14 |
| P130026/S042 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-03-05 |
| P130026/S041 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-02-25 |
| P130026/S039 FDA | Special (Immediate Track) | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-02-15 |
| P130026/S038 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-02-11 |
| P130026/S037 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2019-01-10 |
Source: FDA openFDA, device/pma, records of P130026, retrieved 2026-10-16 02:28 Eastern. 67 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: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:P130026+AND+supplement_number:S079&limit=1
{
"id": "dabba493-ad8c-490b-a192-ec2fcf720a0f",
"pma_key": "P130026/S079",
"pma_number": "P130026",
"supplement_number": "S079",
"applicant": "St Jude Medical",
"trade_name": "TactiCath Contact Force Ablation Catheter, Sensor Enabled",
"generic_name": "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation",
"product_code": "OAE",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2022-08-31",
"decision_code": "OK30",
"supplement_type": "30-Day Notice",
"supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
"date_received": "2022-08-01",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130026&s=S079",
"verified_at": "2026-10-16T06:51:33.307+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": "2026-10-16T06:51:33.307+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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