PMA P090013
- Device
- CapSureFix MRI Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S325
- Product code
- LWP
- Decision date
- 2025-06-05
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- approval for updates to void dimensional inspection criteria
Current openFDA PMA Record#
- Device
- CapSureFix MRI Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S335
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2025-06-05
- Decision code
- APPR
- Date received
- 2025-01-06
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for updates to void dimensional inspection criteria