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 | ENPULSE IMPLANTABLE PULSE GENERATOR, MODELS E1DR01, E1DR03, E1DR06, E1DR21 AND MODEL 9991 V 2.0 APPLICATION SOFTWARE |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S036 |
Date Received | 03/02/2004 |
Decision Date | 03/31/2004 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ADDITION OF THE ATRIAL CAPTURE MANAGEMENT (ACM) AND POST MODE SWITCH OVERDRIVE PACING (PMOP) FEATURES TO ENPULSE IMPLANTABLE PULSE GENERATOR MODELS E1DR01, E1DR03, E1DR06, AND E1DR21. IN ADDITION, YOU REQUESTED APPROVAL FOR MINOR UPDATES TO THE ASSOCIATED PROGRAMMER SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENPULSE IMPLANTABLE PULSE GENERATOR MODELS E1DR01, E1DR03, E1DR06, E1DR21 AND MODEL 9991 V 2.0 APPLICATION SOFTWARE. |
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