|
Device | ST JUDE MEDICAL HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S094 |
Date Received | 01/17/2006 |
Decision Date | 02/16/2006 |
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 CONNECTOR AND CRYSTAL COMPONENTS OF THE TRANSMITTER USED IN THE HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM. |