|
Device | MAESTRO(R) II MODEL 534 PACEMAKER SYSTEM |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | CARDIAC CONTROL SYSTEMS, INC. 3 COMMERCE BLVD. PALM COAST, FL 32164 |
PMA Number | P860027 |
Supplement Number | S012 |
Date Received | 06/12/1997 |
Decision Date | 07/29/1997 |
Product Code |
LWP |
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 THE MAESTRO II MODEL 534 PACEMAKER SYSTEM. |