PMA P090013S099
- Device
- CAPSUREFIX MRI LEAD, REVO MRI IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S099
- Product code
- LWP
- Decision date
- 2013-07-23
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
Current openFDA PMA Record#
- Device
- CAPSUREFIX MRI LEAD, REVO MRI IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S099
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2013-07-23
- Decision code
- APPR
- Date received
- 2013-05-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.