Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath (truncated in the FDA record)

Supplement S116 to premarket approval P030031. Product code OAD. Decision 28 April 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	P030031	pma_number
Supplement number	S116	supplement_number
Applicant	Biosense Webster, Inc.	applicant
Trade name	Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath (truncated in the FDA record)	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	2021-03-31	date_received
Decision date	2021-04-28	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/S116, retrieved 2026-10-16 02:28 Eastern. Public domain (CC0).

Product code

The FDA classification record for the code on this record.

OAD

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Device class 3 · Review panel CV

All records with this codeClassification record on FDA

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:S116&limit=1

{
  "id": "0b0c0602-d624-4d7e-8043-b6aa288aeba1",
  "pma_key": "P030031/S116",
  "pma_number": "P030031",
  "supplement_number": "S116",
  "applicant": "Biosense Webster, Inc.",
  "trade_name": "Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath",
  "generic_name": "catheter, percutaneous, cardiac ablation, for treatment of atrial flutter",
  "product_code": "OAD",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2021-04-28",
  "decision_code": "OK30",
  "supplement_type": "30-Day Notice",
  "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
  "date_received": "2021-03-31",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030031&s=S116",
  "verified_at": "2026-10-16T06:48:42.739+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": "2026-10-16T06:48:42.739+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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