PMA P080006S032
- Device
- MODEL 4296 ATTAIN ABILITY PLUS LV LEAD AND MODEL 4396 ATTAIN ABILITY STRAIGHT LV LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S032
- Product code
- OJX
- Decision date
- 2011-07-21
- Classification
- Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Approval order statement
- UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.
Current openFDA PMA Record#
- Device
- MODEL 4296 ATTAIN ABILITY PLUS LV LEAD AND MODEL 4396 ATTAIN ABILITY STRAIGHT LV LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S032
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2011-07-21
- Decision code
- OK30
- Date received
- 2011-06-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPDATING A TEST PROCEDURE IN RESPONSE TO A NEW STANDARD.