Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Device class 3 · Review panel CV
FDA PMA supplement record
P150005/S081
INTELLANAV MIFI™ Open-Irrigated Ablation Catheters
Supplement S081 to premarket approval P150005. Product code OAD. Decision 16 February 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 | P150005 | pma_number |
| Supplement number | S081 | supplement_number |
| Applicant | Boston Scientific Corp | applicant |
| Trade name | INTELLANAV MIFI™ Open-Irrigated 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 | 2023-11-21 | date_received |
| Decision date | 2024-02-16 | decision_date |
| Decision code | APPR | decision_code |
| Supplement type | Real-Time Process | supplement_type |
| Supplement reason | Change Design/Components/Specifications/Material | supplement_reason |
Source: FDA openFDA, device/pma, P150005/S081, 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 |
|---|---|---|---|
| P150005/S090 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2025-12-05 |
| P150005/S091 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-10-17 |
| P150005/S088 FDA | Normal 180 Day Track No User Fee | Labeling Change - Indications/instructions/shelf life/tradename | 2025-09-02 |
| P150005/S089 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-08-14 |
| P150005/S087 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-03-31 |
| P150005/S086 FDA | Real-Time Process | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-11-14 |
| P150005/S079 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2024-07-17 |
| P150005/S085 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-07-12 |
| P150005/S084 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2024-06-25 |
| P150005/S077 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-04-05 |
| P150005/S083 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2024-03-25 |
| P150005/S082 FDA | Real-Time Process | Labeling Change - Indications/instructions/shelf life/tradename | 2024-03-12 |
| P150005/S074 FDA | Panel Track | Change Design/Components/Specifications/Material | 2024-02-26 |
| P150005/S081 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2024-02-16 |
| P150005/S080 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-12-12 |
| P150005/S076 FDA | Real-Time Process | Labeling Change - Indications/instructions/shelf life/tradename | 2023-07-17 |
| P150005/S075 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-04-27 |
| P150005/S072 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2022-11-21 |
| P150005/S073 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-11-15 |
| P150005/S071 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-09-21 |
| P150005/S070 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-02-25 |
| P150005/S069 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-02-22 |
| P150005/S068 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-12-10 |
| P150005/S067 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-09-07 |
| P150005/S066 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-08-06 |
| P150005/S061 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2021-08-05 |
| P150005/S065 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-07-21 |
| P150005/S064 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-07-20 |
| P150005/S063 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-07-14 |
| P150005/S062 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-03-03 |
| P150005/S058 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2020-12-18 |
| P150005/S060 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-12-15 |
| P150005/S059 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-12-11 |
| P150005/S057 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2020-10-09 |
| P150005/S056 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-06-04 |
| P150005/S054 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2020-05-29 |
| P150005/S055 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-05-28 |
| P150005/S053 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-05-19 |
| P150005/S049 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2020-04-17 |
| P150005/S052 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-02-19 |
| P150005/S051 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2020-01-27 |
| P150005/S050 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-11-07 |
| P150005/S048 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-10-07 |
| P150005/S047 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2019-08-23 |
| P150005/S045 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2019-06-17 |
| P150005/S043 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2019-05-29 |
| P150005/S046 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-05-23 |
| P150005/S044 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-05-03 |
| P150005/S042 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-04-18 |
| P150005/S039 FDA | Normal 180 Day Track | Change Design/Components/Specifications/Material | 2019-01-28 |
| P150005/S041 FDA | 135 Review Track For 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-01-09 |
Source: FDA openFDA, device/pma, records of P150005, retrieved 2026-10-16 02:28 Eastern. 51 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:P150005+AND+supplement_number:S081&limit=1
{
"id": "7fd1b032-7774-4153-a2b5-72fdfd24d75a",
"pma_key": "P150005/S081",
"pma_number": "P150005",
"supplement_number": "S081",
"applicant": "Boston Scientific Corp",
"trade_name": "INTELLANAV MIFI Open-Irrigated Ablation Catheters",
"generic_name": "catheter, percutaneous, cardiac ablation, for treatment of atrial flutter",
"product_code": "OAD",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2024-02-16",
"decision_code": "APPR",
"supplement_type": "Real-Time Process",
"supplement_reason": "Change Design/Components/Specifications/Material",
"date_received": "2023-11-21",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150005&s=S081",
"verified_at": "2026-10-16T06:52:04.835+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": "2026-10-16T06:52:04.835+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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