|
Device | INTEGRITY U DR MODEL 5336 AND SR MODEL 5136 PULSE GENERATORS |
Generic Name | implantable pacemaker Pulse-generator |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S081 |
Date Received | 11/16/2000 |
Decision Date | 12/12/2000 |
Product Codes |
DTB DXY KRG |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR PULSE GENERATOR MODELS INTEGRITY U DR MODEL 5336 AND SR MODEL 5136 PULSE GENERATORS. |