Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICD, Primo MRI VR ICD, (truncated in the FDA record)

Supplement S959 to premarket approval P980016. Product code LWS. Decision 16 July 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	P980016	pma_number
Supplement number	S959	supplement_number
Applicant	Medtronic Cardiac Rhythm Disease Management	applicant
Trade name	Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICD, Primo MRI VR ICD, (truncated in the FDA record)	trade_name
Generic name	Implantable cardioverter defibrillator (non-CRT)	generic_name
Product code	LWS	product_code
Advisory committee	Cardiovascular	advisory_committee_description
Date received	2026-06-16	date_received
Decision date	2026-07-16	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, P980016/S959, retrieved 2026-09-19 21:55 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 56 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
P980016 FDA	original approval	empty	1998-10-09
P980016/S963 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-31
P980016/S962 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-31
P980016/S961 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-31
P980016/S960 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-22
P980016/S959 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-16
P980016/S955 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2026-06-25
P980016/S958 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-05-15
P980016/S957 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-04-30
P980016/S951 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2026-04-30
P980016/S956 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-04-28
P980016/S954 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-03-27
P980016/S953 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-03-06
P980016/S952 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-03-04
P980016/S949 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-02-12
P980016/S947 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-02-11
P980016/S948 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-02-10
P980016/S945 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-01-23
P980016/S946 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-01-16
P980016/S944 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-01-05

Source: FDA openFDA, device/pma, records of P980016, retrieved 2026-09-19 21:55 Eastern. 20 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.

First seen by ArrHub’s weekly snapshot: 2026-09-20 08:40 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:P980016+AND+supplement_number:S959&limit=1

{
  "id": "791db54c-c50d-40e6-ab13-9d2b84c1ebe8",
  "pma_key": "P980016/S959",
  "pma_number": "P980016",
  "supplement_number": "S959",
  "applicant": "Medtronic Cardiac Rhythm Disease Management",
  "trade_name": "Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICD, Primo MRI VR ICD,",
  "generic_name": "Implantable cardioverter defibrillator (non-CRT)",
  "product_code": "LWS",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2026-07-16",
  "decision_code": "OK30",
  "supplement_type": "30-Day Notice",
  "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
  "date_received": "2026-06-16",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980016&s=S959",
  "verified_at": "2026-09-20T02:05:55.826+00:00",
  "created_at": "2026-09-20T01:55:45.395466+00:00",
  "collected_at": "2026-09-20T01:55:31.069+00:00",
  "last_checked_at": null
}

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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