TactiFlex™ Ablation Catheter, Sensor Enabled™

Supplement S034 to premarket approval P220013. Product code OAE. Decision 22 September 2026.

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	P220013	pma_number
Supplement number	S034	supplement_number
Applicant	ABBOTT MEDICAL	applicant
Trade name	TactiFlex™ Ablation Catheter, Sensor Enabled™	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	2026-08-10	date_received
Decision date	2026-09-22	decision_date
Decision code	APPR	decision_code
Supplement type	135 Review Track For 30-Day Notice	supplement_type
Supplement reason	Process Change - Manufacturer/Sterilizer/Packager/Supplier	supplement_reason

Source: FDA openFDA, device/pma, P220013/S034, retrieved 2026-10-15 16:01 Eastern. Public domain (CC0).

Product code

The FDA classification record for the code on this record.

OAE

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

Device class 3 · Review panel CV

All records with this codeClassification record on FDA

ArrHub vocabulary

Electrophysiology

OAE is one of the 60 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
P220013 FDA	original approval	empty	2023-05-18
P220013/S034 FDA	135 Review Track For 30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-09-22
P220013/S033 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2026-08-07
P220013/S030 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2026-07-23
P220013/S031 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-06-05
P220013/S032 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-05-29
P220013/S022 FDA	Normal 180 Day Track	Labeling Change - Indications/instructions/shelf life/tradename	2026-05-28
P220013/S029 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-05-15
P220013/S027 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-02-03
P220013/S026 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-01-15
P220013/S025 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-01-08

Source: FDA openFDA, device/pma, records of P220013, retrieved 2026-10-15 16:01 Eastern. 11 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.

First seen by ArrHub’s weekly snapshot: 2026-10-15 17:24 Eastern.

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:P220013+AND+supplement_number:S034&limit=1

{
  "id": "bd53d253-cff0-43e7-8039-edcff1325666",
  "pma_key": "P220013/S034",
  "pma_number": "P220013",
  "supplement_number": "S034",
  "applicant": "ABBOTT MEDICAL",
  "trade_name": "TactiFlex Ablation Catheter, Sensor Enabled",
  "generic_name": "Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation",
  "product_code": "OAE",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2026-09-22",
  "decision_code": "APPR",
  "supplement_type": "135 Review Track For 30-Day Notice",
  "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
  "date_received": "2026-08-10",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220013&s=S034",
  "verified_at": "2026-10-15T21:05:53.853+00:00",
  "created_at": "2026-10-15T20:01:55.624421+00:00",
  "collected_at": "2026-10-15T20:01:55.441+00:00",
  "last_checked_at": "2026-10-15T21:05:53.853+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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