|
Device | Attain Performa Lead Models 4298, 4398, 4598 |
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 | S115 |
Date Received | 08/31/2017 |
Decision Date | 09/22/2017 |
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 Process update for silicone seals used in quadripolar left ventricular lead models. |