PMA P090013S244
- Device
- CAPSUREFIX MRI SURESCAN LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S244
- Product code
- LWP
- Decision date
- 2017-05-06
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for the Astra SR and DR Implantable Pulse Generators.
Current openFDA PMA Record#
- Device
- CAPSUREFIX MRI SURESCAN LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S244
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2017-05-06
- Decision code
- APPR
- Date received
- 2016-12-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the Astra SR and DR Implantable Pulse Generators.