NVN · Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
· Class 3
Overview
| Product Code | NVN |
|---|---|
| Device Name | Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
Drug eluting permanent RV or RA pacemaker electrodes are used with compatible pacemakers or implantable cardioverter defibrillators (ICD) or cardiac rhythm therapy (CRT) devices to deliver pacing pulses to the heart.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P130010 | VEGA Steroid-Eluting Endocardial Leads (VEGA R45, VEGA R52, and VEGA R58) | MicroPort CRM USA, Inc. | May 17, 2023 | APPR |
| P030036 | MEDTRONIC SELECTSECURE LEAD MODEL 3830 | Medtronic Cardiac Rhythm Disease Management | Aug 3, 2005 | APPR |
| P020030 | STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD | MicroPort CRM USA, Inc. | Jun 17, 2004 | APPR |
| P960006 | SWEET TIP(R) RX STEROID ELUTING LEAD | Boston Scientific | Oct 2, 1998 | APPR |
| P960030 | PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS | ABBOTT MEDICAL | Jan 29, 1998 | APPR |
| P960013 | TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS | ABBOTT MEDICAL | Jun 20, 1997 | APPR |
| P960004 | THINLINE ENDOCARDIAL PACING LEADS | Boston Scientific | Nov 12, 1996 | APPR |
| P950024 | MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695 | Medtronic, Inc. | Sep 6, 1996 | APPR |
| P950001 | SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285 | Boston Scientific | May 8, 1996 | APPR |
| P930039 | MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568 | Medtronic, Inc. | Mar 29, 1996 | APPR |
| P850089 | CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS | Medtronic Cardiac Rhythm Disease Management | Jul 29, 1986 | APPR |
| P830061 | STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING | Medtronic Cardiac Rhythm Disease Management | Jul 29, 1986 | APPR |
Top Applicants
- Boston Scientific — 3 clearances
- Medtronic Cardiac Rhythm Disease Management — 3 clearances
- ABBOTT MEDICAL — 2 clearances
- Medtronic, Inc. — 2 clearances
- MicroPort CRM USA, Inc. — 2 clearances
