PMA P090013S286
- Device
- CapSureFix MRI Lead, Revo MRI SureScan IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S286
- Product code
- LWP
- Decision date
- 2018-06-11
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Add a blood or tissue contacting component endotoxin assessment/monitoring program.
Current openFDA PMA Record#
- Device
- CapSureFix MRI Lead, Revo MRI SureScan IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S286
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2018-06-11
- Decision code
- OK30
- Date received
- 2018-05-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a blood or tissue contacting component endotoxin assessment/monitoring program.