PMA P090013S225
- Device
- CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S225
- Product code
- LWP
- Decision date
- 2016-10-12
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for the 1.5T/3T MR Conditional Evera MRI and Visia AF MRI DF-1 ICDs, 1.5T/3T MR Conditional Labeling of approved Sprint Quattro Secure Lead Models 6935 and 6947, and 3T MR Conditional labeling of Visia AF MRI DF4 ICDs.
Current openFDA PMA Record#
- Device
- CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S225
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2016-10-12
- Decision code
- APPR
- Date received
- 2016-04-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the 1.5T/3T MR Conditional Evera MRI and Visia AF MRI DF-1 ICDs, 1.5T/3T MR Conditional Labeling of approved Sprint Quattro Secure Lead Models 6935 and 6947, and 3T MR Conditional labeling of Visia AF MRI DF4 ICDs.