Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

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	NVN	product_code
Device name	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	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 NVN, 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
2026-08-05	Medtronic Cardiac Rhythm Disease Management	SelectSecure Lead 3830	P030036/S161 FDA
2026-06-26	ABBOTT MEDICAL	IsoFlex Leads	P960030/S085 FDA
2026-06-26	ABBOTT MEDICAL	Tendril STS Leads; Ultipace Leads; Optisense Leads	P960013/S134 FDA
2026-06-24	Medtronic, Inc.	CapSureFix Novus Lead (5076), CapSureFix Novus Lead (4076), Vitatron Crystalline Active Fixation Lead (ICQ09B)	P930039/S278 FDA
2026-06-24	Medtronic Cardiac Rhythm Disease Management	CapSure Sense Lead (4074), CapSure Sense Lead (4574), Vitatron Crystalline Lead (ICM09B, ICM09JB)	P830061/S236 FDA
2026-06-24	Medtronic Cardiac Rhythm Disease Management	SelectSecure Lead (3830)	P030036/S160 FDA
2026-06-11	ABBOTT MEDICAL	UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isoflex Low Voltage 1944/1948, Ten (truncated in the FDA record)	P960030/S084 FDA
2026-06-11	ABBOTT MEDICAL	UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isoflex Low Voltage 1944/1948, Ten (truncated in the FDA record)	P960013/S133 FDA
2026-06-03	Boston Scientific	ThinLine/FineLine Family of Endocardial Pacing Leads Models: 4456, 4457, 4469, 4470, 4471, 4479, 4480	P960004/S116 FDA
2026-05-28	Medtronic Cardiac Rhythm Disease Management	SelectSecure Lead Model 3830	P030036/S158 FDA
2026-05-15	Boston Scientific	Fixation Tool (Model 6616)	P960006/S059 FDA
2026-05-15	Boston Scientific	Stylet (Models 6033, 6034, 6036, 6037, 6039, 6040, 6042, 6043, 6053, 6054, 6055, 6058, 6059, 6062, 6063, 6064, 6065, 606 (truncated in the FDA record)	P960004/S115 FDA
2026-04-15	Medtronic, Inc.	CapSure Epicardial Pacing Lead (4968), CapSure Epicardial Pacing Lead (4965)	P950024/S117 FDA
2026-04-15	Medtronic, Inc.	CapSureFix Lead 5568, CapSureFix Novus Lead (5076), CapSureFix Novus Lead (4076)	P930039/S277 FDA
2026-04-15	Medtronic Cardiac Rhythm Disease Management	CapSure SP Novus Lead (5092); CapSure SP Novus Lead (5592); CapSure SP Novus Lead (5594); CapSure SP Z Lead, CapSure Z N (truncated in the FDA record)	P850089/S174 FDA
2026-04-15	Medtronic Cardiac Rhythm Disease Management	Adhesive; CapSure Sense Lead (4073,4074); CapSure Sense Lead (4574); CapSure SP Novus Lead (4092); CapSure SP Novus Lead (truncated in the FDA record)	P830061/S235 FDA
2026-04-15	Medtronic Cardiac Rhythm Disease Management	Anchoring Sleeve Kit; SelectSecure Lead	P030036/S159 FDA
2026-04-10	Boston Scientific	Fixation Tool Model 6616	P960006/S058 FDA
2026-04-10	Boston Scientific	Straight Lead Stylets Limber Models 6033, 6034; Straight Lead Stylets Firm Models 6036, 6037; J Shaped Lead Stylets Limb (truncated in the FDA record)	P960004/S114 FDA
2026-04-02	Biotronik, Inc.	Solia CSP S Leads	P950037/S288 FDA
2026-03-06	Medtronic Cardiac Rhythm Disease Management	SelectSecure Lead	P030036/S157 FDA
2026-02-19	ABBOTT MEDICAL	IsoFlex	P960030/S080 FDA
2026-02-19	ABBOTT MEDICAL	Tendril STS; OptiSense; UltiPace	P960013/S129 FDA
2026-02-12	Biotronik, Inc.	Solia CSP S 53; Solia CSP S 60	P950037/S280 FDA
2026-02-10	Medtronic, Inc.	CapSure Epicardial Pacing Lead (4965); CapSure Epicardial Pacing Lead (4968)	P950024/S116 FDA
2026-02-10	Medtronic, Inc.	CapSureFix Novus Lead (5076); CapSureFix Novus Lead (4076); Vitatron Crystalline ActFix Lead (ICF09B); Vitatron Crystall (truncated in the FDA record)	P930039/S275 FDA
2026-02-10	Medtronic Cardiac Rhythm Disease Management	CapSure SP Novus Lead 5092 CapSure SP Z Lead 5033 Vitatron Impulse II Lead IHP09, IHP09B, IHP09JB	P850089/S173 FDA
2026-02-10	Medtronic Cardiac Rhythm Disease Management	CapSure Sense Lead 4574 CapSure Sense Lead 4073, 4074 Vitatron Crystalline Lead ICM09, ICM09B, ICM09JB Vitatron Excellen (truncated in the FDA record)	P830061/S233 FDA
2026-02-10	Medtronic Cardiac Rhythm Disease Management	SelectSecure Lead	P030036/S156 FDA
2026-01-15	MicroPort CRM USA, Inc.	VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58)	P130010/S005 FDA
2026-01-08	Medtronic Cardiac Rhythm Disease Management	SelectSecure Lead 3830	P030036/S155 FDA
2023-05-17	MicroPort CRM USA, Inc.	VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58)	P130010 FDA
2005-08-03	Medtronic Cardiac Rhythm Disease Management	MEDTRONIC SELECTSECURE LEAD MODEL 3830	P030036 FDA
1998-10-02	Boston Scientific	SWEET TIP(R) RX STEROID ELUTING LEAD	P960006 FDA
1998-01-29	ABBOTT MEDICAL	PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS	P960030 FDA
1997-06-20	ABBOTT MEDICAL	TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS	P960013 FDA
1996-11-12	Boston Scientific	THINLINE ENDOCARDIAL PACING LEADS	P960004 FDA
1996-09-06	Medtronic, Inc.	MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695	P950024 FDA
1996-03-29	Medtronic, Inc.	MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568	P930039 FDA
1986-07-29	Medtronic Cardiac Rhythm Disease Management	CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS	P850089 FDA
1986-07-29	Medtronic Cardiac Rhythm Disease Management	STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING	P830061 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

NVN 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:NVN

{
  "id": "fda_product_code:NVN",
  "vocabulary": "fda_product_code",
  "term": "NVN",
  "definition": "Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes",
  "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:NVN",
  "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": "2026-09-20T01:19:17.068798+00:00",
  "updated_at": "2026-09-20T01:19:02.786+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.