|
Device | 3500/3510 PROGRAMMER |
Generic Name | implantable pacemaker Pulse-generator |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S067 |
Date Received | 07/22/1999 |
Decision Date | 01/28/2000 |
Product Codes |
DTB DXY KRG |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval is for the Model 3304 Programmer Software for use with the Model 3500 and 3510 Programmers. The device is indicated for programming and interrogation of implanted St. Jude pacemakers. |