PMA P090013S203
- Device
- REVO MRI SURESCAN IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S203
- Product code
- LWP
- Decision date
- 2015-10-23
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- REMOVAL OF VARIOUS VISUAL INSPECTIONS AND RE-ORDERING OF STEPS IN THE WORK INSTRUCTIONS IMPLEMENTED IN THE AUTOMATIC LINE OF FINAL PACKAGING.
Current openFDA PMA Record#
- Device
- REVO MRI SURESCAN IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S203
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2015-10-23
- Decision code
- OK30
- Date received
- 2015-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REMOVAL OF VARIOUS VISUAL INSPECTIONS AND RE-ORDERING OF STEPS IN THE WORK INSTRUCTIONS IMPLEMENTED IN THE AUTOMATIC LINE OF FINAL PACKAGING.