Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | MEDTRONIC(R) THERA(TM) PULSE GENERATORS |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | Medtronic, Inc. 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P890003 |
Supplement Number | S037 |
Date Received | 04/06/1995 |
Decision Date | 10/31/1995 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFIED REDUCED SIZE VERSIONS OF THE THERA DR (APPROVED UNDER P890003/S31). THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME:MEDTRONIC THERA-I SERIES AND PRODIGY PULSE GENERATORS, MODEL 9879 SOFTWARE, AND MODELS 9759/9772 MEMORYMODS. |
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