Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Device class 3 · Review panel CV
FDA PMA supplement record
P010068/S065
CELSIUS, NAVISTAR and EZ STEER
Supplement S065 to premarket approval P010068. Product code OAD. Decision 22 September 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 | P010068 | pma_number |
| Supplement number | S065 | supplement_number |
| Applicant | Biosense Webster, Inc. | applicant |
| Trade name | CELSIUS, NAVISTAR and EZ STEER | 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 | 2021-05-17 | date_received |
| Decision date | 2021-09-22 | decision_date |
| Decision code | APPR | decision_code |
| Supplement type | Real-Time Process | supplement_type |
| Supplement reason | Labeling Change - Indications/instructions/shelf life/tradename | supplement_reason |
Source: FDA openFDA, device/pma, P010068/S065, 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 |
|---|---|---|---|
| P010068/S074 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-02-26 |
| P010068/S075 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-02-25 |
| P010068/S073 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-11-20 |
| P010068/S072 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-11-15 |
| P010068/S071 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-06-12 |
| P010068/S070 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-09-30 |
| P010068/S069 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2022-09-09 |
| P010068/S067 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2022-03-08 |
| P010068/S068 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-09-22 |
| P010068/S065 FDA | Real-Time Process | Labeling Change - Indications/instructions/shelf life/tradename | 2021-09-22 |
| P010068/S066 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-07-09 |
| P010068/S063 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-04-28 |
| P010068/S064 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-04-27 |
| P010068/S062 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2021-04-07 |
| P010068/S061 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-02-02 |
| P010068/S060 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-09-24 |
| P010068/S059 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-04-16 |
| P010068/S058 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-02-26 |
Source: FDA openFDA, device/pma, records of P010068, retrieved 2026-10-16 02:28 Eastern. 18 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:P010068+AND+supplement_number:S065&limit=1
{
"id": "e89c5f2f-4cab-413b-b2fc-f51908bdb326",
"pma_key": "P010068/S065",
"pma_number": "P010068",
"supplement_number": "S065",
"applicant": "Biosense Webster, Inc.",
"trade_name": "CELSIUS, NAVISTAR and EZ STEER",
"generic_name": "catheter, percutaneous, cardiac ablation, for treatment of atrial flutter",
"product_code": "OAD",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2021-09-22",
"decision_code": "APPR",
"supplement_type": "Real-Time Process",
"supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
"date_received": "2021-05-17",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010068&s=S065",
"verified_at": "2026-10-16T06:47:55.877+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": "2026-10-16T06:47:55.877+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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