PMA P090013S216
- Device
- RENO MRI SURESCAN IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S216
- Product code
- LWP
- Decision date
- 2016-03-01
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Implementation of routine bacterial endotoxin testing.
Current openFDA PMA Record#
- Device
- RENO MRI SURESCAN IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S216
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2016-03-01
- Decision code
- OK30
- Date received
- 2016-02-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of routine bacterial endotoxin testing.