PMA P090013S312
- Device
- CapSureFix MRI Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S312
- Product code
- LWP
- Decision date
- 2020-12-08
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Reduce the sampling monitoring plan for non-viable air particles in controlled environment areas.
Current openFDA PMA Record#
- Device
- CapSureFix MRI Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S312
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-12-08
- Decision code
- OK30
- Date received
- 2020-12-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduce the sampling monitoring plan for non-viable air particles in controlled environment areas.