Leadless Pacemaker

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	PNJ	product_code
Device name	Leadless Pacemaker	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 PNJ, 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	ABBOTT MEDICAL	Aveir VR Leadless System	P150035/S041 FDA
2026-07-31	Medtronic, Inc.	Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01)	P150033/S229 FDA
2026-07-31	Medtronic, Inc.	Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01)	P150033/S228 FDA
2026-07-21	ABBOTT MEDICAL	Aveir™ Leadless System	P150035/S035 FDA
2026-06-17	ABBOTT MEDICAL	AVEIR Patient Transmitter LSRM01	P150035/S040 FDA
2026-06-11	ABBOTT MEDICAL	The AVEIR Leadless Pacemaker (LP)	P150035/S039 FDA
2026-06-04	Medtronic, Inc.	Micra™ Scalable Catheter Delivery System (Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS (truncated in the FDA record)	P150033/S224 FDA
2026-05-29	ABBOTT MEDICAL	Aveir VR (LSCD111); DR Delivery Catheter (LSCD201)	P150035/S038 FDA
2026-05-08	Medtronic, Inc.	Micra Cathode Press Station 2	P150033/S227 FDA
2026-04-30	Medtronic, Inc.	Micra AV TPS; Micra AV2 TPS; Micra TPS; Micra VR2 TPS	P150033/S226 FDA
2026-04-30	Medtronic, Inc.	Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01)	P150033/S223 FDA
2026-04-24	ABBOTT MEDICAL	Aveir Leadless System	P150035/S037 FDA
2026-04-22	Medtronic, Inc.	Micra Transcatheter Pacing System	P150033/S225 FDA
2026-04-03	ABBOTT MEDICAL	AVEIR Leadless Pacemaker, ventricular (LSP112V, LSP202V); Aveir Delivery Catheter (LSCD111, LSCD201)	P150035/S036 FDA
2026-02-23	ABBOTT MEDICAL	Aveir DR Delivery Catheter (LSCD201)	P150035/S034 FDA
2026-02-23	Medtronic, Inc.	Miera AV TPS; Miera TPS	P150033/S222 FDA
2026-02-19	ABBOTT MEDICAL	Aveir™ VR Leadless Pacemaker, Aveir™ Leadless Pacemaker (Right Ventricular)	P150035/S026 FDA
2026-02-11	Medtronic, Inc.	Micra Transcatheter Pacing System (MC1VR01), Micra AV Transcatheter Pacing System (MC1AVR1), Micra VR2 Transcatheter Pac (truncated in the FDA record)	P150033/S221 FDA
2026-02-10	Medtronic, Inc.	Micra AV2 TPS; Micra VR2 TPS	P150033/S220 FDA
2022-03-31	ABBOTT MEDICAL	Aveir VR Leadless System	P150035 FDA
2016-04-06	Medtronic, Inc.	MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM	P150033 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

PNJ 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:PNJ

{
  "id": "fda_product_code:PNJ",
  "vocabulary": "fda_product_code",
  "term": "PNJ",
  "definition": "Leadless Pacemaker",
  "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:PNJ",
  "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": "2026-09-20T01:19:15.737131+00:00",
  "updated_at": "2026-09-20T01:19:01.451+00:00"
}

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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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