Therapy Cool Flex, Path Duo, Safire Duo, MediGuide Enabled Ablation Catheter; Mediguide Enabled

Supplement S060 to premarket approval P110016. Product code OAD. Decision 11 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	P110016	pma_number
Supplement number	S060	supplement_number
Applicant	ABBOTT MEDICAL	applicant
Trade name	Therapy Cool Flex, Path Duo, Safire Duo, MediGuide Enabled Ablation Catheter; Mediguide Enabled	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	2019-03-15	date_received
Decision date	2019-04-11	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, P110016/S060, retrieved 2026-10-16 02:28 Eastern. Public domain (CC0).

Product code

The FDA classification record for the code on this record.

OAD

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Device class 3 · Review panel CV

All records with this codeClassification record on FDA

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
P110016 FDA	original approval	empty	2012-01-25
P110016/S095 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2026-08-07
P110016/S094 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-06-05
P110016/S093 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-04-09
P110016/S092 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-01-15
P110016/S091 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-01-08
P110016/S089 FDA	Normal 180 Day Track No User Fee	Postapproval Study Protocol	2025-10-16
P110016/S090 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2025-05-06
P110016/S088 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2025-04-10
P110016/S087 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2024-12-13
P110016/S084 FDA	Normal 180 Day Track	Change Design/Components/Specifications/Material	2023-11-29
P110016/S086 FDA	Normal 180 Day Track No User Fee	Location Change - Manufacturer/Sterilizer/Packager/Supplier	2023-10-26
P110016/S085 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2023-08-17
P110016/S083 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2023-05-02
P110016/S082 FDA	Normal 180 Day Track No User Fee	Postapproval Study Protocol	2023-02-24
P110016/S080 FDA	Panel Track	Change Design/Components/Specifications/Material	2022-12-14
P110016/S081 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2022-12-08
P110016/S079 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2021-10-14
P110016/S078 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2021-09-22
P110016/S077 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2021-06-25
P110016/S076 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2021-05-18
P110016/S075 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2021-05-04
P110016/S074 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2021-03-24
P110016/S073 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2021-03-12
P110016/S072 FDA	Real-Time Process	Labeling Change - Indications/instructions/shelf life/tradename	2021-01-06
P110016/S070 FDA	Normal 180 Day Track	Change Design/Components/Specifications/Material	2020-11-02
P110016/S071 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2020-10-16
P110016/S069 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2020-06-04
P110016/S067 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2020-04-24
P110016/S068 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2020-04-16
P110016/S066 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2020-03-04
P110016/S065 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2019-10-25
P110016/S064 FDA	Special (Immediate Track)	Labeling Change - Indications/instructions/shelf life/tradename	2019-10-09
P110016/S063 FDA	Normal 180 Day Track No User Fee	Location Change - Manufacturer/Sterilizer/Packager/Supplier	2019-08-22
P110016/S062 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2019-05-07
P110016/S061 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2019-04-23
P110016/S060 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2019-04-11
P110016/S059 FDA	Normal 180 Day Track No User Fee	Location Change - Manufacturer/Sterilizer/Packager/Supplier	2019-03-05
P110016/S058 FDA	Special (Immediate Track)	Labeling Change - Indications/instructions/shelf life/tradename	2019-01-10

Source: FDA openFDA, device/pma, records of P110016, retrieved 2026-10-16 02:28 Eastern. 39 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: rule:prefix. 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:P110016+AND+supplement_number:S060&limit=1

{
  "id": "acadd3e0-c40f-4e69-8184-20608d7daf6c",
  "pma_key": "P110016/S060",
  "pma_number": "P110016",
  "supplement_number": "S060",
  "applicant": "ABBOTT MEDICAL",
  "trade_name": "Therapy Cool Flex, Path Duo, Safire Duo, MediGuide Enabled Ablation Catheter; Mediguide Enabled",
  "generic_name": "catheter, percutaneous, cardiac ablation, for treatment of atrial flutter",
  "product_code": "OAD",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2019-04-11",
  "decision_code": "OK30",
  "supplement_type": "30-Day Notice",
  "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
  "date_received": "2019-03-15",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110016&s=S060",
  "verified_at": "2026-10-16T06:50:47.063+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": "2026-10-16T06:50:47.063+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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