|
Device | Attain Stability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
Generic Name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
Applicant | MEDTRONIC Inc. 710 MEDTRONIC PARKWAY NE MINNEAPOLIS, MN 55432 |
PMA Number | P080006 |
Supplement Number | S169 |
Date Received | 02/16/2022 |
Decision Date | 03/14/2022 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Modification to the electrode coating inspection process at Medtronic's supplier-Heraeus located in Hanau, Germany. |