Cardiac Ablation Percutaneous Catheter
Device class 3 · Review panel CV
FDA PMA supplement record
P040014/S047
Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series)
Supplement S047 to premarket approval P040014. Product code LPB. Decision 16 December 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 | P040014 | pma_number |
| Supplement number | S047 | supplement_number |
| Applicant | Irvine Biomedical, Inc. | applicant |
| Trade name | Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series) | trade_name |
| Generic name | Cardiac ablation percutaneous catheter | generic_name |
| Product code | LPB | product_code |
| Advisory committee | Cardiovascular | advisory_committee_description |
| Date received | 2022-10-28 | date_received |
| Decision date | 2022-12-16 | 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, P040014/S047, 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 |
|---|---|---|---|
| P040014 FDA | original approval | empty | 2005-01-14 |
| P040014/S052 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-09-03 |
| P040014/S051 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2026-08-07 |
| P040014/S050 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-04-10 |
| P040014/S049 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-10-15 |
| P040014/S048 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2023-11-29 |
| P040014/S047 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-12-16 |
| P040014/S046 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-11-15 |
| P040014/S045 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-10-14 |
| P040014/S044 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-05-04 |
| P040014/S043 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-03-24 |
| P040014/S042 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2021-03-12 |
| P040014/S040 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2020-11-02 |
| P040014/S041 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-10-16 |
| P040014/S039 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2020-04-24 |
| P040014/S038 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-03-04 |
| P040014/S037 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-08-28 |
| P040014/S036 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-04-11 |
| P040014/S035 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2019-01-10 |
Source: FDA openFDA, device/pma, records of P040014, retrieved 2026-10-16 02:28 Eastern. 19 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
Abbott
The register name above is resolved to its organisation under ArrHub’s alias table. Method: manual. 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:P040014+AND+supplement_number:S047&limit=1
{
"id": "19cde73d-86dd-4f60-9227-04dae0aa9e20",
"pma_key": "P040014/S047",
"pma_number": "P040014",
"supplement_number": "S047",
"applicant": "Irvine Biomedical, Inc.",
"trade_name": "Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series)",
"generic_name": "Cardiac ablation percutaneous catheter",
"product_code": "LPB",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2022-12-16",
"decision_code": "APPR",
"supplement_type": "Normal 180 Day Track No User Fee",
"supplement_reason": "Location Change - Manufacturer/Sterilizer/Packager/Supplier",
"date_received": "2022-10-28",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040014&s=S047",
"verified_at": "2026-10-16T06:49:02.871+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": "2026-10-16T06:49:02.871+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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