PMA P090013S092
- Device
- REVO MRI SURESCAN PACKING SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S092
- Product code
- LWP
- Decision date
- 2013-05-14
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- REPLACING THE TEST USED FOR IN-PROCESS MONITORING OF AN INNER INSULATION PARAMETER.
Current openFDA PMA Record#
- Device
- REVO MRI SURESCAN PACKING SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S092
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2013-05-14
- Decision code
- OK30
- Date received
- 2013-04-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACING THE TEST USED FOR IN-PROCESS MONITORING OF AN INNER INSULATION PARAMETER.