PMA P080006S071
- Device
- ATTAIN ABILITY LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S071
- Product code
- OJX
- Decision date
- 2014-09-18
- Classification
- Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Approval order statement
- UPDATE TO THE COMPONENT AND LEAD DRAWINGS FOR THE RING MONOLITHIC CONTROLLED RELEASE DEVICE (MCRD) COMPONENT, AND THE CORRESPONDING MANUFACTURING PROCESSES, TO INCLUDE ADDITIONAL INSPECTION CRITERIA.
Current openFDA PMA Record#
- Device
- ATTAIN ABILITY LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S071
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2014-09-18
- Decision code
- OK30
- Date received
- 2014-08-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPDATE TO THE COMPONENT AND LEAD DRAWINGS FOR THE RING MONOLITHIC CONTROLLED RELEASE DEVICE (MCRD) COMPONENT, AND THE CORRESPONDING MANUFACTURING PROCESSES, TO INCLUDE ADDITIONAL INSPECTION CRITERIA.