Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Device class 3 · Review panel CV
FDA PMA supplement record
P020025/S117
Blazere II Ablation Catheters, Blazer II XP Ablation Catheters, Blazer Prime Ablation Catheters
Supplement S117 to premarket approval P020025. Product code OAD. Decision 16 April 2019.
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 | P020025 | pma_number |
| Supplement number | S117 | supplement_number |
| Applicant | Boston Scientific | applicant |
| Trade name | Blazere II Ablation Catheters, Blazer II XP Ablation Catheters, Blazer Prime Ablation Catheters | 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 | 2019-03-21 | date_received |
| Decision date | 2019-04-16 | 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, P020025/S117, 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 |
|---|---|---|---|
| P020025/S147 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-10-17 |
| P020025/S146 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-08-14 |
| P020025/S145 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-03-31 |
| P020025/S144 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-03-20 |
| P020025/S141 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2024-07-17 |
| P020025/S139 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-04-05 |
| P020025/S143 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2024-02-16 |
| P020025/S142 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-12-12 |
| P020025/S140 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-07-27 |
| P020025/S138 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-04-27 |
| P020025/S137 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-11-15 |
| P020025/S136 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-09-21 |
| P020025/S135 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-02-25 |
| P020025/S134 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-02-22 |
| P020025/S133 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-09-07 |
| P020025/S132 FDA | Real-Time Process | Labeling Change - Indications/instructions/shelf life/tradename | 2021-08-17 |
| P020025/S129 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2021-08-05 |
| P020025/S130 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-04-08 |
| P020025/S128 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-06-17 |
| P020025/S127 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2020-06-04 |
| P020025/S126 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-05-19 |
| P020025/S125 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-02-19 |
| P020025/S124 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-02-07 |
| P020025/S123 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2020-01-27 |
| P020025/S122 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-11-07 |
| P020025/S121 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-08-23 |
| P020025/S120 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2019-06-17 |
| P020025/S118 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2019-05-29 |
| P020025/S119 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-05-03 |
| P020025/S117 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-04-16 |
| P020025/S113 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2019-01-28 |
| P020025/S115 FDA | 135 Review Track For 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-01-09 |
Source: FDA openFDA, device/pma, records of P020025, retrieved 2026-10-16 02:28 Eastern. 32 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
Boston Scientific
The register name above is resolved to its organisation under ArrHub’s alias table. Method: rule:normalize. 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:P020025+AND+supplement_number:S117&limit=1
{
"id": "4c3dca7d-2890-4150-ad81-7dc801ddb23b",
"pma_key": "P020025/S117",
"pma_number": "P020025",
"supplement_number": "S117",
"applicant": "Boston Scientific",
"trade_name": "Blazere II Ablation Catheters, Blazer II XP Ablation Catheters, Blazer Prime Ablation Catheters",
"generic_name": "catheter, percutaneous, cardiac ablation, for treatment of atrial flutter",
"product_code": "OAD",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2019-04-16",
"decision_code": "OK30",
"supplement_type": "30-Day Notice",
"supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
"date_received": "2019-03-21",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020025&s=S117",
"verified_at": "2026-10-16T06:48:02.593+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": "2026-10-16T06:48:02.593+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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