PMA P090013S315
- Device
- CapSureFix MRI Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S315
- Product code
- LWP
- Decision date
- 2021-06-23
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Changes to the cleaning process of stylet components manufactured at the supplier.
Current openFDA PMA Record#
- Device
- CapSureFix MRI Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S315
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-06-23
- Decision code
- OK30
- Date received
- 2021-06-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the cleaning process of stylet components manufactured at the supplier.