PMA P830061S137
- Device
- CapSure Sense MRI SureScan Leads
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P830061
- Supplement
- S137
- Product code
- NVN
- Decision date
- 2017-04-25
- Classification
- Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- Approval of 1.5 and 3T MR Conditional Labeling for SelectSecure MRI SureScan Lead Model 3830.
Current openFDA PMA Record#
- Device
- CapSure Sense MRI SureScan Leads
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P830061
- Supplement
- S137
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2017-04-25
- Decision code
- APPR
- Date received
- 2016-11-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval of 1.5 and 3T MR Conditional Labeling for SelectSecure MRI SureScan Lead Model 3830.