PMA P080006S054
- Device
- ATTAIN ABILITY LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S054
- Product code
- OJX
- Decision date
- 2013-07-23
- Classification
- Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- 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
- ATTAIN ABILITY LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S054
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- 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.