- Device
- CapSureFix MRI Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S305
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-03-06
- Decision code
- OK30
- Date received
- 2020-02-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer two incoming inspection activities for device components from Medtronic Rice Creek to Medtronic Puerto Rico Operations Company Villalba/Juncos sites.