Cardiac Ablation Percutaneous Catheter
Device class 3 · Review panel CV
FDA PMA supplement record
P990071/S060
Smartablate System Interface Cable
Supplement S060 to premarket approval P990071. Product code LPB. Decision 15 November 2024.
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 | P990071 | pma_number |
| Supplement number | S060 | supplement_number |
| Applicant | Biosense Webster, Inc. | applicant |
| Trade name | Smartablate System Interface Cable | trade_name |
| Generic name | Cardiac ablation percutaneous catheter | generic_name |
| Product code | LPB | product_code |
| Advisory committee | Cardiovascular | advisory_committee_description |
| Date received | 2024-03-12 | date_received |
| Decision date | 2024-11-15 | decision_date |
| Decision code | APPR | decision_code |
| Supplement type | Normal 180 Day Track No User Fee | supplement_type |
| Supplement reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier | supplement_reason |
Source: FDA openFDA, device/pma, P990071/S060, 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 |
|---|---|---|---|
| P990071/S068 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2025-12-23 |
| P990071/S067 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-09-15 |
| P990071/S066 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-03-28 |
| P990071/S065 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-02-26 |
| P990071/S063 FDA | Real-Time Process | Labeling Change - Indications/instructions/shelf life/tradename | 2025-02-11 |
| P990071/S064 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-01-22 |
| P990071/S062 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-11-20 |
| P990071/S060 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-11-15 |
| P990071/S061 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2024-10-30 |
| P990071/S059 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-02-19 |
| P990071/S058 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-02-16 |
| P990071/S057 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-06-12 |
| P990071/S055 FDA | Normal 180 Day Track | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-01-24 |
| P990071/S056 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-09-30 |
| P990071/S054 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-06-08 |
| P990071/S053 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-03-15 |
| P990071/S051 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2022-03-08 |
| P990071/S047 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2021-12-23 |
| P990071/S046 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-09-23 |
| P990071/S052 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-09-22 |
| P990071/S050 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-07-09 |
| P990071/S048 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-04-28 |
| P990071/S049 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-04-27 |
| P990071/S045 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-10-01 |
| P990071/S044 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2020-07-17 |
| P990071/S043 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-04-16 |
| P990071/S040 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-05-08 |
| P990071/S042 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2019-04-29 |
Source: FDA openFDA, device/pma, records of P990071, retrieved 2026-10-16 02:28 Eastern. 28 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:P990071+AND+supplement_number:S060&limit=1
{
"id": "506026a3-c362-494b-b0da-9eb142ba33af",
"pma_key": "P990071/S060",
"pma_number": "P990071",
"supplement_number": "S060",
"applicant": "Biosense Webster, Inc.",
"trade_name": "Smartablate System Interface Cable",
"generic_name": "Cardiac ablation percutaneous catheter",
"product_code": "LPB",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2024-11-15",
"decision_code": "APPR",
"supplement_type": "Normal 180 Day Track No User Fee",
"supplement_reason": "Location Change - Manufacturer/Sterilizer/Packager/Supplier",
"date_received": "2024-03-12",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990071&s=S060",
"verified_at": "2026-10-16T06:54:25.582+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": "2026-10-16T06:54:25.582+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.
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