|
Device | SENSOLOG III MODEL 2033B & DIALOG II MODEL 2037B |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P880006 |
Supplement Number | S007 |
Date Received | 05/10/1990 |
Decision Date | 05/30/1990 |
Withdrawal Date
|
05/07/2018 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |