|
Device | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM |
Generic Name | System, hemodynamic, implantable |
Applicant | Abbott Medical 387 Technology Circle, NW Suite 500 Atlanta, GA 30313 |
PMA Number | P100045 |
Supplement Number | S019 |
Date Received | 01/10/2017 |
Decision Date | 05/19/2017 |
Product Code |
MOM |
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 hardware and software updates to equipment used to measure atmospheric and device parameters used in-process during production. |