|
Device | ST JUDE MEDICAL AFFINITY/IDENTITY/VERITY/INTERGRITY/VICTORY/ZEPHYR PACEMAKERS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S172 |
Date Received | 12/19/2008 |
Decision Date | 01/16/2009 |
Product Code |
NVZ |
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 MODIFICATIONS TO THE MOISTURE GETTER DISPENSING SYSTEM. |