PMA P080006S120
- Device
- Attain Ability and Performa Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S120
- Product code
- OJX
- Decision date
- 2018-04-23
- Classification
- Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Approval order statement
- Automate certain manufacturing processes for stylet assemblies.
Current openFDA PMA Record#
- Device
- Attain Ability and Performa Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S120
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2018-04-23
- Decision code
- OK30
- Date received
- 2018-04-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automate certain manufacturing processes for stylet assemblies.