PMA P090013S294
- Device
- REVO MRI SURESCAN IPG AND PACING SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S294
- Product code
- LWP
- Decision date
- 2018-12-03
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Align the bioburden test work instruction with the test method validations.
Current openFDA PMA Record#
- Device
- REVO MRI SURESCAN IPG AND PACING SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S294
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2018-12-03
- Decision code
- OK30
- Date received
- 2018-11-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Align the bioburden test work instruction with the test method validations.