PMA P090013S164
- Device
- CAPSUREFIX MRI SURE AND SCAN LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S164
- Product code
- LWP
- Decision date
- 2016-03-18
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for a design change to the lead helix electrode and a manufacturing site change and the related update to analytical methods and tightened specifications proposed for drug related elements of the medical devices.
Current openFDA PMA Record#
- Device
- CAPSUREFIX MRI SURE AND SCAN LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S164
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2016-03-18
- Decision code
- APPR
- Date received
- 2014-12-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change to the lead helix electrode and a manufacturing site change and the related update to analytical methods and tightened specifications proposed for drug related elements of the medical devices.