Defibrillator, Implantable, Dual-Chamber

FDA product classification. Device class 3. Review panel CV.

Classification

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
Product code	MRM	product_code
Device name	Defibrillator, Implantable, Dual-Chamber	device_name
Device class	3	device_class
Review panel	CV	review_panel
Regulation number	empty	regulation_number
Medical specialty	Unknown	medical_specialty

Source: FDA openFDA, device/classification, product code MRM, as held in ArrHub’s controlled vocabulary with its citation. Public domain (CC0).

PMA records with this code

Every verified record ArrHub holds under the code, newest first.

Decision	Applicant	Device	Record
2026-06-24	Biotronik, Inc.	Acticor 7 VR-T DX (429525); Acticor 7 VR-T DF4 ProMRI (429526); Rivacor 3 VR-T DF4 ProMRI (429574); Rivacor 5 VR-T DF4 P (truncated in the FDA record)	P050023/S212 FDA
2026-06-24	Biotronik, Inc.	Acticor Sky DR-T (481987); Rivacor Sky DR-T (481982); Rivacor Rise DR-T (482018); Rivacor Aura DR-T (482014)	P000009/S131 FDA
2026-05-07	Biotronik, Inc.	Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX, (truncated in the FDA record)	P050023/S210 FDA
2026-05-07	Biotronik, Inc.	Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-T	P000009/S129 FDA
2026-04-24	Biotronik, Inc.	Renamic Neo	P050023/S207 FDA
2026-04-24	Biotronik, Inc.	Renamic Neo	P000009/S127 FDA
2026-03-05	Biotronik, Inc.	Acticor 7 VR-T (429526); Rivacor 7 VR-T (429536); Rivacor 5 VR-T (429565); Rivacor 3 VR-T (429574); Acticor 7 VR-T DX (4 (truncated in the FDA record)	P050023/S208 FDA
2026-02-11	Biotronik, Inc.	TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD	P050023/S205 FDA
2026-02-11	Biotronik, Inc.	PHYLAX AV ICD SYSTEM	P000009/S125 FDA
2026-02-03	Biotronik, Inc.	TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD	P050023/S206 FDA
2026-02-03	Biotronik, Inc.	PHYLAX AV ICD SYSTEM	P000009/S126 FDA
2006-08-10	Biotronik, Inc.	TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD	P050023 FDA
2000-09-29	Biotronik, Inc.	PHYLAX AV ICD SYSTEM	P000009 FDA

510(k) clearances with this code

Every verified record ArrHub holds under the code, newest first.

None in the verified view.

ArrHub

What ArrHub adds to the record. Everything above this line is the agency’s; everything here is ArrHub’s, dated and attributed.

ArrHub vocabulary

Electrophysiology

MRM 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.

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/classification.json?search=product_code:MRM

{
  "id": "fda_product_code:MRM",
  "vocabulary": "fda_product_code",
  "term": "MRM",
  "definition": "Defibrillator, Implantable, Dual-Chamber",
  "attrs": {
    "device_class": "3",
    "review_panel": "CV",
    "medical_specialty": "Unknown",
    "regulation_number": ""
  },
  "jurisdiction": "US",
  "authority": "FDA",
  "ep_relevant": true,
  "source_url": "https://api.fda.gov/device/classification.json?search=product_code:MRM",
  "verified_by": "Bruno Deslauriers",
  "verified_at": "2026-09-20T01:22:27.524165+00:00",
  "notes": "Fetched from https://open.fda.gov/apis/device/classification/",
  "created_at": "2026-09-20T01:19:25.63946+00:00",
  "updated_at": "2026-09-20T01:19:11.347+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.