Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
NVN is the FDA product code for Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes, a class III device type. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- NVN
- Device name
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
- FDA definition
- 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.
- Device class
- Class III
- Review panel
- Unknown
- Submission type
- PMA
- Implant
- Yes
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this code- Abbott Medical
- BIOTRONIK AG
- BIOTRONIK Apm II Pte. Ltd
- BIOTRONIK SE & Co. KG
- Boston Scientific Corporation
- Corcym Inc.
- Heraeus Medical Components Caribe, Inc.
- Isomedix Operations Inc
- Medtronic Distribution Center
- Medtronic Engineering and Innovation Center (MEIC)
- Medtronic Europe SARL
- Medtronic Puerto Rico Operations Co., Juncos
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