PMA P090013S253
- Device
- Revo MRI SureScan IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S253
- Product code
- LWP
- Decision date
- 2017-04-28
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Changes to the manufacturing process flow at an integrated circuit component supplier as well as the addition of visual inspection requirements.
Current openFDA PMA Record#
- Device
- Revo MRI SureScan IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S253
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2017-04-28
- Decision code
- OK30
- Date received
- 2017-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the manufacturing process flow at an integrated circuit component supplier as well as the addition of visual inspection requirements.