|
Device | ACUITY STEERABLE STYLET ACCESSORY |
Generic Name | Permanent defibrillator electrodes |
Applicant | GUIDANT CORP. 4100 HAMLINE AVENUE NORTH ST. PAUL, MN 55112-5798 |
PMA Number | P050046 |
Supplement Number | S009 |
Date Received | 01/26/2011 |
Decision Date | 06/29/2011 |
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 | No |
Approval Order Statement APPROVAL FOR ACCEPTANCE OF A CHANGE TO RELOCATE A SENSOR ON WIRE GRINDING EQUIPMENT AND FORMALIZE INSPECTIONS AS ACCEPTANCE ACTIVITIES. |