PMA P090013S313
- Device
- CapSureFix MRI Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S313
- Product code
- LWP
- Decision date
- 2020-12-22
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Manufacturing site located at Medtronic Singapore Operations: 49 Changi South Avenue 2, Nasaco Tech Centre, Singapore 486056.
Current openFDA PMA Record#
- Device
- CapSureFix MRI Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S313
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-12-22
- Decision code
- APPR
- Date received
- 2020-12-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing site located at Medtronic Singapore Operations: 49 Changi South Avenue 2, Nasaco Tech Centre, Singapore 486056.