Implantable Pacemaker Pulse-Generator

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	DXY	product_code
Device name	Implantable Pacemaker Pulse-Generator	device_name
Device class	3	device_class
Review panel	CV	review_panel
Regulation number	870.3610	regulation_number
Medical specialty	Cardiovascular	medical_specialty

Source: FDA openFDA, device/classification, product code DXY, 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
2026-08-27	Biotronik, Inc.	Solia CSP S	P950037/S297 FDA
2026-07-21	ABBOTT MEDICAL	Assurity, Assurity+, Endurity, Accent family of Pacemakers	P880086/S345 FDA
2026-07-01	Biotronik, Inc.	Solia T 53, Solia T 60, Solia S 45, Solia S 53, Solia S 60, Solia CSP S 53, Solia CSP S 60	P950037/S295 FDA
2026-05-28	Biotronik, Inc.	Siello T 53, Siello T 60, Siello JT 45, Siello JT 53, Solia T 53, Solia T 60, Solia JT 45, Solia JT 53, Siello S 45, Sie (truncated in the FDA record)	P950037/S293 FDA
2026-05-15	Biotronik, Inc.	Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes	P950037/S292 FDA
2026-05-07	Biotronik, Inc.	Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 SR-T, Evity 8 S (truncated in the FDA record)	P950037/S290 FDA
2026-04-24	Biotronik, Inc.	Renamic Neo	P950037/S285 FDA
2026-04-24	ABBOTT MEDICAL	Assurity, Assurity+, Endurity, Accent family of Pacemakers	P880086/S346 FDA
2026-03-30	Biotronik, Inc.	Amvia-Solvia Pulse Generators Scan Duration Extension	P950037/S282 FDA
2026-03-27	Biotronik, Inc.	Pulse Generator, Permanent Implantable Edora 8 DR-T Evity 8 DR-T Enitra 8 DR-T Enticos 8 DR-T Evity 6 DR-T Enitra 6 DR-T (truncated in the FDA record)	P950037/S287 FDA
2026-03-05	Biotronik, Inc.	Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En (truncated in the FDA record)	P950037/S286 FDA
2026-02-11	Biotronik, Inc.	DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS	P950037/S283 FDA
2026-02-03	Biotronik, Inc.	DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS	P950037/S284 FDA
1996-10-11	Biotronik, Inc.	DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS	P950037 FDA
1989-08-21	ABBOTT MEDICAL	ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS	P880086 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

DXY 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:DXY

{
  "id": "fda_product_code:DXY",
  "vocabulary": "fda_product_code",
  "term": "DXY",
  "definition": "Implantable Pacemaker Pulse-Generator",
  "attrs": {
    "device_class": "3",
    "review_panel": "CV",
    "medical_specialty": "Cardiovascular",
    "regulation_number": "870.3610"
  },
  "jurisdiction": "US",
  "authority": "FDA",
  "ep_relevant": true,
  "source_url": "https://api.fda.gov/device/classification.json?search=product_code:DXY",
  "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": "2026-09-20T01:09:12.526317+00:00",
  "updated_at": "2026-09-20T01:19:00.109+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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