|
Device | FAMILY OF CRT-PS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S199 |
Date Received | 03/22/2011 |
Decision Date | 05/10/2011 |
Product Code |
NVZ |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR TIGHTER SCREENING LIMITS AND THE INCLUSION OF A REFLOW THERMAL CONDITIONING DURING THE MANUFACTURE OF TANTALUM CAPACITOR COMPONENTS. |