PMA P090013S218
- Device
- REVO MRI SURESCAN IPG AND PACING SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S218
- Product code
- LWP
- Decision date
- 2016-03-11
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Replacement of two pick and place machines with one new system used in hybrid manufacturing.
Current openFDA PMA Record#
- Device
- REVO MRI SURESCAN IPG AND PACING SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S218
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2016-03-11
- Decision code
- OK30
- Date received
- 2016-02-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of two pick and place machines with one new system used in hybrid manufacturing.