NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH

Supplement S084 to premarket approval P040036. Product code LPB. Decision 8 March 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	P040036	pma_number
Supplement number	S084	supplement_number
Applicant	Biosense Webster, Inc.	applicant
Trade name	NAVISTAR THERMOCOOL, 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	2021-06-30	date_received
Decision date	2022-03-08	decision_date
Decision code	APPR	decision_code
Supplement type	Normal 180 Day Track	supplement_type
Supplement reason	Change Design/Components/Specifications/Material	supplement_reason

Source: FDA openFDA, device/pma, P040036/S084, retrieved 2026-10-16 02:28 Eastern. Public domain (CC0).

Product code

The FDA classification record for the code on this record.

LPB

Cardiac Ablation Percutaneous Catheter

Device class 3 · Review panel CV

All records with this codeClassification record on FDA

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:S084&limit=1

{
  "id": "92112a2d-a3d2-4640-8b53-e38c95d8443f",
  "pma_key": "P040036/S084",
  "pma_number": "P040036",
  "supplement_number": "S084",
  "applicant": "Biosense Webster, Inc.",
  "trade_name": "NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH",
  "generic_name": "Cardiac ablation percutaneous catheter",
  "product_code": "LPB",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2022-03-08",
  "decision_code": "APPR",
  "supplement_type": "Normal 180 Day Track",
  "supplement_reason": "Change Design/Components/Specifications/Material",
  "date_received": "2021-06-30",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040036&s=S084",
  "verified_at": "2026-10-16T06:49:15.621+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": "2026-10-16T06:49:15.621+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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