Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Device class 3 · Review panel CV
FDA PMA supplement record
P030031/S106
Thermocool Smarttouch SF
Supplement S106 to premarket approval P030031. Product code OAD. Decision 26 June 2020.
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 | P030031 | pma_number |
| Supplement number | S106 | supplement_number |
| Applicant | Biosense Webster, Inc. | applicant |
| Trade name | Thermocool Smarttouch SF | 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 | 2020-06-05 | date_received |
| Decision date | 2020-06-26 | 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, P030031/S106, 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 |
|---|---|---|---|
| P030031 FDA | original approval | empty | 2004-11-05 |
| P030031/S146 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-09-15 |
| P030031/S142 FDA | Normal 180 Day Track | Labeling Change - Indications/instructions/shelf life/tradename | 2026-09-02 |
| P030031/S141 FDA | Panel Track | Change Design/Components/Specifications/Material | 2026-07-01 |
| P030031/S143 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2026-06-30 |
| P030031/S144 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-06-10 |
| P030031/S138 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-02-26 |
| P030031/S139 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-02-25 |
| P030031/S137 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-11-20 |
| P030031/S135 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-11-15 |
| P030031/S136 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2024-05-24 |
| P030031/S134 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-09-28 |
| P030031/S129 FDA | Normal 180 Day Track | Labeling Change - Indications/instructions/shelf life/tradename | 2023-08-03 |
| P030031/S126 FDA | Normal 180 Day Track | Labeling Change - Indications/instructions/shelf life/tradename | 2023-07-18 |
| P030031/S133 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-06-12 |
| P030031/S132 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-05-03 |
| P030031/S131 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-03-10 |
| P030031/S128 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-09-30 |
| P030031/S127 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2022-09-09 |
| P030031/S122 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2022-03-08 |
| P030031/S125 FDA | Real-Time Process | Labeling Change - Indications/instructions/shelf life/tradename | 2022-02-01 |
| P030031/S110 FDA | Normal 180 Day Track | Labeling Change - Indications/instructions/shelf life/tradename | 2021-11-12 |
| P030031/S124 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-09-22 |
| P030031/S120 FDA | Real-Time Process | Labeling Change - Indications/instructions/shelf life/tradename | 2021-09-22 |
| P030031/S121 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-07-09 |
| P030031/S118 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2021-05-13 |
| P030031/S116 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-04-28 |
| P030031/S117 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-04-27 |
| P030031/S115 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2021-04-07 |
| P030031/S114 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2021-04-07 |
| P030031/S109 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2021-03-26 |
| P030031/S113 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-03-02 |
| P030031/S112 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-02-02 |
| P030031/S102 FDA | Normal 180 Day Track No User Fee | Labeling Change - PAS | 2021-01-28 |
| P030031/S111 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-01-22 |
| P030031/S100 FDA | Panel Track | Labeling Change - Indications/instructions/shelf life/tradename | 2020-09-30 |
| P030031/S108 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-09-24 |
| P030031/S107 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-07-10 |
| P030031/S106 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-06-26 |
| P030031/S105 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-04-30 |
| P030031/S104 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-04-16 |
| P030031/S103 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-03-31 |
| P030031/S101 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-02-26 |
| P030031/S099 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-08-02 |
| P030031/S095 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2019-04-29 |
| P030031/S097 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-04-19 |
| P030031/S091 FDA | Normal 180 Day Track No User Fee | Labeling Change - Indications/instructions/shelf life/tradename | 2019-04-12 |
| P030031/S092 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-04-02 |
| P030031/S094 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2019-03-26 |
| P030031/S096 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-03-08 |
Source: FDA openFDA, device/pma, records of P030031, retrieved 2026-10-16 02:28 Eastern. 50 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
Johnson & Johnson
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:P030031+AND+supplement_number:S106&limit=1
{
"id": "3b37c7d2-d40c-4dac-a22f-fa0f15bfa74f",
"pma_key": "P030031/S106",
"pma_number": "P030031",
"supplement_number": "S106",
"applicant": "Biosense Webster, Inc.",
"trade_name": "Thermocool Smarttouch SF",
"generic_name": "catheter, percutaneous, cardiac ablation, for treatment of atrial flutter",
"product_code": "OAD",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2020-06-26",
"decision_code": "OK30",
"supplement_type": "30-Day Notice",
"supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
"date_received": "2020-06-05",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030031&s=S106",
"verified_at": "2026-10-16T06:48:37.64+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": "2026-10-16T06:48:37.64+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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