PMA P090013S202
- Device
- CAPSUREFIX MRI SURESCAN
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S202
- Product code
- LWP
- Decision date
- 2016-02-01
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI/Compia MRI Quad CRT-D SureScan devices, programmer application software Model SW034 and extension of MR Conditional labeling for the Attain Ability and Attain Performa lead models as MRI SureScan labeled leads.
Current openFDA PMA Record#
- Device
- CAPSUREFIX MRI SURESCAN
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S202
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2016-02-01
- Decision code
- APPR
- Date received
- 2015-09-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI/Compia MRI Quad CRT-D SureScan devices, programmer application software Model SW034 and extension of MR Conditional labeling for the Attain Ability and Attain Performa lead models as MRI SureScan labeled leads.