|
Device | MITRACLIP CLIP 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 | S006 |
Date Received | 06/16/2014 |
Decision Date | 07/16/2014 |
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 SECOND SUPPLIER, A CHANGE IN THE HEAT TREATMENT PROCESS AND ESTABLISHMENT OF A DEFINED RANGE OF ACCEPTABLE RAW MATERIAL HARDNESS FOR THE ACTUATOR COUPLER OF THE MITRACLIP CLIP DELIVERY SYSTEM. |