EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) high voltage (HV) Capacitor

Supplement S216 to premarket approval P110042. Product code LWS. Decision 2 October 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	P110042	pma_number
Supplement number	S216	supplement_number
Applicant	Boston Scientific Corporation	applicant
Trade name	EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) high voltage (HV) Capacitor	trade_name
Generic name	Implantable cardioverter defibrillator (non-CRT)	generic_name
Product code	LWS	product_code
Advisory committee	Cardiovascular	advisory_committee_description
Date received	2026-09-10	date_received
Decision date	2026-10-02	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, P110042/S216, 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
P110042 FDA	original approval	empty	2012-09-28
P110042/S216 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-10-02
P110042/S215 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-23
P110042/S210 FDA	Normal 180 Day Track No User Fee	Postapproval Study Protocol	2026-07-07
P110042/S214 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-07-01
P110042/S211 FDA	Real-Time Process	Change Design/Components/Specifications/Material	2026-07-01
P110042/S213 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-06-03
P110042/S212 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-06-03
P110042/S203 FDA	Normal 180 Day Track	Change Design/Components/Specifications/Material	2026-02-20
P110042/S208 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-02-13
P110042/S204 FDA	135 Review Track For 30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-01-08

Source: FDA openFDA, device/pma, records of P110042, 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.

Resolution

No verified alias in ArrHub’s table; the name stands as the register spells it.

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:P110042+AND+supplement_number:S216&limit=1

{
  "id": "893be37b-0ea6-4f92-9036-cde79b1e84d6",
  "pma_key": "P110042/S216",
  "pma_number": "P110042",
  "supplement_number": "S216",
  "applicant": "Boston Scientific Corporation",
  "trade_name": "EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) high voltage (HV) Capacitor",
  "generic_name": "Implantable cardioverter defibrillator (non-CRT)",
  "product_code": "LWS",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2026-10-02",
  "decision_code": "OK30",
  "supplement_type": "30-Day Notice",
  "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
  "date_received": "2026-09-10",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110042&s=S216",
  "verified_at": "2026-10-15T21:05:46.756+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": "2026-10-15T21:05:46.756+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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