Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Device class 3 · Review panel CV
FDA PMA supplement record
P100010/S118
Arctic Front Cardiac CryoAblation System: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoabl (truncated in the FDA record)
Supplement S118 to premarket approval P100010. Product code OAE. Decision 16 December 2021.
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 | P100010 | pma_number |
| Supplement number | S118 | supplement_number |
| Applicant | Medtronic Cryocath, LP | applicant |
| Trade name | Arctic Front Cardiac CryoAblation System: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoabl (truncated in the FDA record) | trade_name |
| Generic name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | generic_name |
| Product code | OAE | product_code |
| Advisory committee | Cardiovascular | advisory_committee_description |
| Date received | 2021-07-16 | date_received |
| Decision date | 2021-12-16 | decision_date |
| Decision code | APPR | decision_code |
| Supplement type | Normal 180 Day Track No User Fee | supplement_type |
| Supplement reason | Postapproval Study Protocol | supplement_reason |
Source: FDA openFDA, device/pma, P100010/S118, 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
OAE 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 |
|---|---|---|---|
| P100010 FDA | original approval | empty | 2010-12-17 |
| P100010/S154 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2026-09-25 |
| P100010/S152 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2026-08-06 |
| P100010/S153 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2026-04-23 |
| P100010/S150 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-03-27 |
| P100010/S151 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2025-03-18 |
| P100010/S149 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-11-13 |
| P100010/S148 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-07-03 |
| P100010/S147 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-06-07 |
| P100010/S145 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-03-29 |
| P100010/S146 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-03-26 |
| P100010/S141 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2024-03-25 |
| P100010/S144 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2024-01-08 |
| P100010/S143 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-11-29 |
| P100010/S142 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-10-06 |
| P100010/S140 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-09-19 |
| P100010/S139 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2023-08-21 |
| P100010/S138 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-06-01 |
| P100010/S131 FDA | 135 Review Track For 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-04-27 |
| P100010/S137 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-03-06 |
| P100010/S136 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-02-28 |
| P100010/S135 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-01-19 |
| P100010/S134 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2023-01-19 |
| P100010/S133 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-12-07 |
| P100010/S132 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-11-09 |
| P100010/S130 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-09-23 |
| P100010/S129 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-08-24 |
| P100010/S128 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-06-01 |
| P100010/S127 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-05-06 |
| P100010/S125 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-03-16 |
| P100010/S126 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-03-15 |
| P100010/S123 FDA | Real-Time Process | Labeling Change - Indications/instructions/shelf life/tradename | 2022-03-07 |
| P100010/S124 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2022-01-20 |
| P100010/S118 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2021-12-16 |
| P100010/S122 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-12-14 |
| P100010/S121 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-11-17 |
| P100010/S120 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-11-09 |
| P100010/S119 FDA | Real-Time Process | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-11-05 |
| P100010/S117 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-09-10 |
| P100010/S116 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-08-06 |
| P100010/S110 FDA | Panel Track | Labeling Change - Indications/instructions/shelf life/tradename | 2021-06-18 |
| P100010/S114 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2021-06-10 |
| P100010/S115 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-05-13 |
| P100010/S113 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2021-03-03 |
| P100010/S108 FDA | Normal 180 Day Track No User Fee | Postapproval Study Protocol | 2021-02-11 |
| P100010/S112 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-12-15 |
| P100010/S111 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-12-15 |
| P100010/S109 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-11-09 |
| P100010/S107 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2020-08-13 |
| P100010/S106 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-06-25 |
| P100010/S098 FDA | Panel Track | Labeling Change - Indications/instructions/shelf life/tradename | 2020-06-23 |
| P100010/S105 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-06-18 |
| P100010/S104 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-05-20 |
| P100010/S102 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-03-05 |
| P100010/S103 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-02-24 |
| P100010/S101 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-02-03 |
| P100010/S100 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2020-01-17 |
| P100010/S099 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-12-10 |
| P100010/S097 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-10-18 |
| P100010/S096 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-09-19 |
| P100010/S093 FDA | Real-Time Process | Change Design/Components/Specifications/Material | 2019-06-27 |
| P100010/S095 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-06-17 |
| P100010/S094 FDA | Normal 180 Day Track No User Fee | Location Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-06-04 |
| P100010/S090 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-05-29 |
| P100010/S092 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-05-08 |
| P100010/S091 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-05-03 |
| P100010/S086 FDA | Normal 180 Day Track No User Fee | Labeling Change - Indications/instructions/shelf life/tradename | 2019-05-01 |
| P100010/S089 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-04-03 |
| P100010/S088 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-03-05 |
| P100010/S087 FDA | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 2019-01-03 |
Source: FDA openFDA, device/pma, records of P100010, retrieved 2026-10-16 02:28 Eastern. 70 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
Medtronic
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:P100010+AND+supplement_number:S118&limit=1
{
"id": "5e102923-95c3-4d58-9e53-0b8127536f3f",
"pma_key": "P100010/S118",
"pma_number": "P100010",
"supplement_number": "S118",
"applicant": "Medtronic Cryocath, LP",
"trade_name": "Arctic Front Cardiac CryoAblation System: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoabl",
"generic_name": "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation",
"product_code": "OAE",
"advisory_committee_description": "Cardiovascular",
"decision_date": "2021-12-16",
"decision_code": "APPR",
"supplement_type": "Normal 180 Day Track No User Fee",
"supplement_reason": "Postapproval Study Protocol",
"date_received": "2021-07-16",
"source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100010&s=S118",
"verified_at": "2026-10-16T06:50:06.736+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": "2026-10-16T06:50:06.736+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.
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