Cardiac Ablation Percutaneous Catheter
Device class 3 · Review panel CV
FDA PMA supplement record
P920047/S130
Blazer II Cardiac Ablation System
Supplement S130 to premarket approval P920047. Product code LPB. Decision 27 April 2023.
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 | P920047 | pma_number |
| Supplement number | S130 | supplement_number |
| Applicant | Boston Scientific Corp | applicant |
| Trade name | Blazer II Cardiac Ablation System | trade_name |
| Generic name | Cardiac ablation percutaneous catheter | generic_name |
| Product code | LPB | product_code |
| Advisory committee | Cardiovascular | advisory_committee_description |
| Date received | 2023-03-30 | date_received |
| Decision date | 2023-04-27 | 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, P920047/S130, 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 |
|---|---|---|---|
| P920047/S138 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-10-17 |
| P920047/S137 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-08-14 |
| P920047/S136 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-03-31 |
| P920047/S135 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-03-20 |
| P920047/S133 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2024-07-17 |
| P920047/S131 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-04-05 |
| P920047/S134 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-12-12 |
| P920047/S132 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-07-27 |
| P920047/S130 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-04-27 |
| P920047/S129 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-11-15 |
| P920047/S128 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-09-21 |
| P920047/S127 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-02-25 |
| P920047/S126 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-02-22 |
| P920047/S125 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-09-07 |
| P920047/S124 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2021-08-05 |
| P920047/S123 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2020-06-04 |
| P920047/S122 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-05-19 |
| P920047/S121 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-02-19 |
| P920047/S120 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-02-07 |
| P920047/S119 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2020-01-27 |
| P920047/S118 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-11-07 |
| P920047/S117 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-08-23 |
| P920047/S116 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2019-06-17 |
| P920047/S115 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-05-03 |
| P920047/S114 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-04-16 |
| P920047/S110 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2019-01-28 |
| P920047/S112 FDA | 135 Review Track For 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-01-09 |
Source: FDA openFDA, device/pma, records of P920047, retrieved 2026-10-16 02:28 Eastern. 27 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.
Resolution
No verified alias in ArrHub’s table; the name stands as the register spells it.
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:P920047+AND+supplement_number:S130&limit=1
{
"id": "46598193-9dbf-4dd2-8001-dd278e0a142b",
"pma_key": "P920047/S130",
"pma_number": "P920047",
"supplement_number": "S130",
"applicant": "Boston Scientific Corp",
"trade_name": "Blazer II Cardiac Ablation System",
"generic_name": "Cardiac ablation percutaneous catheter",
"product_code": "LPB",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2023-04-27",
"decision_code": "OK30",
"supplement_type": "30-Day Notice",
"supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
"date_received": "2023-03-30",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P920047&s=S130",
"verified_at": "2026-10-16T06:53:40.999+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": "2026-10-16T06:53:40.999+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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