PMA P090013S023
- Device
- REVO MRI IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S023
- Product code
- LWP
- Decision date
- 2011-06-08
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- CHANGES TO THE NELIPAK SEALER MANUFACTURING PROCESS; INCLUDING ADDITION OF NEW EQUIPMENT, A CHANGE TO THE PROCESS RECIPE SPECIFICATION, AND THE IMPLEMENTATION OF A MONITORING TEST.
Current openFDA PMA Record#
- Device
- REVO MRI IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S023
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2011-06-08
- Decision code
- OK30
- Date received
- 2011-05-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE NELIPAK SEALER MANUFACTURING PROCESS; INCLUDING ADDITION OF NEW EQUIPMENT, A CHANGE TO THE PROCESS RECIPE SPECIFICATION, AND THE IMPLEMENTATION OF A MONITORING TEST.