PMA P090013S309
- Device
- CapSureFix MRI Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S309
- Product code
- LWP
- Decision date
- 2020-10-15
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Transfer chemical and mechanical testing activities to the MPROC Juncos facility.
Current openFDA PMA Record#
- Device
- CapSureFix MRI Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S309
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-10-15
- Decision code
- OK30
- Date received
- 2020-09-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer chemical and mechanical testing activities to the MPROC Juncos facility.