PMA P090013S295
- Device
- CapSureFix MRI Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S295
- Product code
- LWP
- Decision date
- 2018-12-17
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Transfer an intermediate manufacturing step to fill Dexamethasone Sodium Phosphate and Dexamethasone Acetate into vials from Medtronic Energy and Component Center to the Medtronic Cardiac Rhythm Heart Failure Rice Creek Pharma Manufacturing Operations facility and to implement minor process improvements.
Current openFDA PMA Record#
- Device
- CapSureFix MRI Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S295
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2018-12-17
- Decision code
- OK30
- Date received
- 2018-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer an intermediate manufacturing step to fill Dexamethasone Sodium Phosphate and Dexamethasone Acetate into vials from Medtronic Energy and Component Center to the Medtronic Cardiac Rhythm Heart Failure Rice Creek Pharma Manufacturing Operations facility and to implement minor process improvements.