Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569

Supplement S140 to premarket approval P980023. Product code LWS. Decision 25 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	P980023	pma_number
Supplement number	S140	supplement_number
Applicant	Biotronik, Inc.	applicant
Trade name	Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569	trade_name
Generic name	Implantable cardioverter defibrillator (non-CRT)	generic_name
Product code	LWS	product_code
Advisory committee	Cardiovascular	advisory_committee_description
Date received	2025-09-25	date_received
Decision date	2026-09-25	decision_date
Decision code	APPR	decision_code
Supplement type	Normal 180 Day Track	supplement_type
Supplement reason	Change Design/Components/Specifications/Material	supplement_reason

Source: FDA openFDA, device/pma, P980023/S140, retrieved 2026-10-15 16:01 Eastern. Public domain (CC0).

Product code

The FDA classification record for the code on this record.

LWS

Implantable Cardioverter Defibrillator (Non-Crt)

Device class 3 · Review panel CV

All records with this codeClassification record on FDA

ArrHub vocabulary

Electrophysiology

LWS 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
P980023 FDA	original approval	empty	1998-10-27
P980023/S151 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-09-25
P980023/S140 FDA	Normal 180 Day Track	Change Design/Components/Specifications/Material	2026-09-25
P980023/S146 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2026-09-17
P980023/S150 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-09-10
P980023/S148 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-01
P980023/S147 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-06-24
P980023/S145 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-05-07
P980023/S144 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-03-05
P980023/S142 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-02-11
P980023/S143 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-02-03

Source: FDA openFDA, device/pma, records of P980023, 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

Biotronik

The register name above is resolved to its organisation under ArrHub’s alias table. Method: rule:normalize. 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:P980023+AND+supplement_number:S140&limit=1

{
  "id": "ab4fc674-4053-4ed1-99eb-e36d2e61027e",
  "pma_key": "P980023/S140",
  "pma_number": "P980023",
  "supplement_number": "S140",
  "applicant": "Biotronik, Inc.",
  "trade_name": "Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569",
  "generic_name": "Implantable cardioverter defibrillator (non-CRT)",
  "product_code": "LWS",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2026-09-25",
  "decision_code": "APPR",
  "supplement_type": "Normal 180 Day Track",
  "supplement_reason": "Change Design/Components/Specifications/Material",
  "date_received": "2025-09-25",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980023&s=S140",
  "verified_at": "2026-10-15T21:05:58.682+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": "2026-10-15T21:05:58.682+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.

Report a broken link or a record that does not match its source: alerts@arrhub.com. Corrections are published, with their date, at arrhub.com/corrections.