Cardiac Ablation Percutaneous Catheter
Device class 3 · Review panel CV
FDA PMA supplement record
P040036/S078
Thermocool Smarttouch
Supplement S078 to premarket approval P040036. Product code LPB. Decision 2 March 2021.
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 | P040036 | pma_number |
| Supplement number | S078 | supplement_number |
| Applicant | Biosense Webster, Inc. | applicant |
| Trade name | Thermocool Smarttouch | trade_name |
| Generic name | Cardiac ablation percutaneous catheter | generic_name |
| Product code | LPB | product_code |
| Advisory committee | Cardiovascular | advisory_committee_description |
| Date received | 2021-02-23 | date_received |
| Decision date | 2021-03-02 | 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, P040036/S078, 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
LPB 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 |
|---|---|---|---|
| P040036/S101 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-09-15 |
| P040036/S100 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-02-25 |
| P040036/S099 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-11-20 |
| P040036/S097 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-11-15 |
| P040036/S098 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2024-05-24 |
| P040036/S096 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-09-28 |
| P040036/S091 FDA | Normal 180 Day Track | Labeling Change - Indications/instructions/shelf life/tradename | 2023-08-03 |
| P040036/S095 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-06-12 |
| P040036/S094 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-05-03 |
| P040036/S093 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-03-10 |
| P040036/S090 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-09-30 |
| P040036/S089 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2022-09-09 |
| P040036/S084 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2022-03-08 |
| P040036/S087 FDA | Real-Time Process | Labeling Change - Indications/instructions/shelf life/tradename | 2022-02-01 |
| P040036/S086 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-09-22 |
| P040036/S082 FDA | Real-Time Process | Labeling Change - Indications/instructions/shelf life/tradename | 2021-09-22 |
| P040036/S085 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-09-07 |
| P040036/S083 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-07-09 |
| P040036/S080 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-04-28 |
| P040036/S081 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-04-27 |
| P040036/S079 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2021-04-07 |
| P040036/S078 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-03-02 |
| P040036/S077 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-02-02 |
| P040036/S070 FDA | Normal 180 Day Track No User Fee | Labeling Change - PAS | 2021-01-28 |
| P040036/S076 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-01-22 |
| P040036/S075 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-07-10 |
| P040036/S074 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-06-26 |
| P040036/S073 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-04-30 |
| P040036/S072 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-04-16 |
| P040036/S071 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-03-31 |
| P040036/S069 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-02-26 |
| P040036/S068 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-08-02 |
| P040036/S065 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2019-04-29 |
| P040036/S067 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-04-19 |
| P040036/S064 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2019-03-26 |
| P040036/S066 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-03-08 |
Source: FDA openFDA, device/pma, records of P040036, retrieved 2026-10-16 02:28 Eastern. 36 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:P040036+AND+supplement_number:S078&limit=1
{
"id": "dab10209-3d39-4d19-b637-80513b0ffd7a",
"pma_key": "P040036/S078",
"pma_number": "P040036",
"supplement_number": "S078",
"applicant": "Biosense Webster, Inc.",
"trade_name": "Thermocool Smarttouch",
"generic_name": "Cardiac ablation percutaneous catheter",
"product_code": "LPB",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2021-03-02",
"decision_code": "OK30",
"supplement_type": "30-Day Notice",
"supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
"date_received": "2021-02-23",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040036&s=S078",
"verified_at": "2026-10-16T06:49:12.278+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": "2026-10-16T06:49:12.278+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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