|
Device | MITRACLIP DELIVERY SYSTEM |
Generic Name | Mitral valve repair devices |
Applicant | Abbott Medical 177 Country Road B East St. Paul, MN 55117 |
PMA Number | P100009 |
Supplement Number | S008 |
Date Received | 11/19/2014 |
Decision Date | 12/17/2014 |
Product Code |
NKM |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGES RELATED TO THE LASER WELDING SUPPLIER AND ASSOCIATED INCOMING INSPECTIONS. |