|
Device | CAPSURE SP NOVUS |
Generic Name | permanent pacemaker Electrode |
Regulation Number | 870.3680 |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P850089 |
Supplement Number | S040 |
Date Received | 10/01/1998 |
Decision Date | 10/29/1998 |
Product Code |
DTB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for distribution under a new trade name. The devices will be marketed under the trade name Vitatron(R) Excellence SS+ Models IML 49B and IML 49JB and indicated for use with pulse generators as part of a caridac pacing system to provide chronic pacing and sensing of the ventricle. |