Cardiac Ablation Percutaneous Catheter
Device class 3 · Review panel CV
FDA PMA supplement record
P960016/S082
Livewire TC Ablation Catheter
Supplement S082 to premarket approval P960016. Product code LPB. Decision 13 April 2020.
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 | P960016 | pma_number |
| Supplement number | S082 | supplement_number |
| Applicant | St Jude Medical | applicant |
| Trade name | Livewire TC Ablation Catheter | trade_name |
| Generic name | Cardiac ablation percutaneous catheter | generic_name |
| Product code | LPB | product_code |
| Advisory committee | Cardiovascular | advisory_committee_description |
| Date received | 2020-03-23 | date_received |
| Decision date | 2020-04-13 | 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, P960016/S082, 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 |
|---|---|---|---|
| P960016 FDA | original approval | empty | 1999-05-04 |
| P960016/S094 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2026-08-07 |
| P960016/S093 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2026-01-15 |
| P960016/S092 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-04-10 |
| P960016/S090 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2023-11-29 |
| P960016/S091 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-10-26 |
| P960016/S089 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-12-08 |
| P960016/S088 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-10-14 |
| P960016/S087 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-05-18 |
| P960016/S086 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2021-03-12 |
| P960016/S084 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2020-11-02 |
| P960016/S085 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-10-16 |
| P960016/S083 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-06-04 |
| P960016/S081 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-04-16 |
| P960016/S082 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-04-13 |
| P960016/S080 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-10-25 |
| P960016/S079 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-08-22 |
| P960016/S078 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-05-07 |
| P960016/S077 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-03-05 |
| P960016/S076 FDA | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 2019-01-10 |
Source: FDA openFDA, device/pma, records of P960016, retrieved 2026-10-16 02:28 Eastern. 20 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: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:P960016+AND+supplement_number:S082&limit=1
{
"id": "24235545-00a1-4df8-81f8-4599393dd4f8",
"pma_key": "P960016/S082",
"pma_number": "P960016",
"supplement_number": "S082",
"applicant": "St Jude Medical",
"trade_name": "Livewire TC Ablation Catheter",
"generic_name": "Cardiac ablation percutaneous catheter",
"product_code": "LPB",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2020-04-13",
"decision_code": "OK30",
"supplement_type": "30-Day Notice",
"supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
"date_received": "2020-03-23",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960016&s=S082",
"verified_at": "2026-10-16T06:54:03.547+00:00",
"created_at": "2026-10-16T06:28:37.266536+00:00",
"collected_at": "2026-10-16T06:28:22.358+00:00",
"last_checked_at": "2026-10-16T06:54:03.547+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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