|
Device | CAPSURE FIX NOVUS/SUREFIX/VITATRON CRYSTALLINE ACTFIX/PIROUET S+ |
Generic Name | Permanent defibrillator electrodes |
Applicant | Medtronic, Inc. 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P930039 |
Supplement Number | S063 |
Date Received | 10/24/2011 |
Decision Date | 04/06/2012 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR CHANGES TO THE INCOMING MATERIAL SPECIFICATIONS FOR ACTIVE PHARMACEUTICAL INGREDIENTS USED IN THE MANUFACTURE OF STEROID-ELUDING PACEMAKER LEADS. |