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 | ADAPTA,VERSA ,SENSIA IPG, ADVISA DR IPG.ADVISA DR MRI IPG,ENPULSE E1 IPG,ENPULSE E2 IPG, ENRHYTHM IPG,KAPPA D(KAPPA 700) |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S360 |
Date Received | 12/19/2013 |
Decision Date | 02/27/2014 |
Product Code |
NVZ |
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 SOFTWARE CHANGES TO THE MYCARELINK PATIENT MONITOR M2.5 MODEL 24950 WITH MODEL 24955 RF HEAD WHICH SUPPORTS THE DEVICES AND MEDTRONIC¿S REVEAL INSERTABLE CARDIAC MONITORS MODELS 9529, 9528 AND LNQ11. THE MYCARELINK PATIENT MONITOR IS INDICATED FOR TRANSMISSION OF IMPLANTABLE DEVICE DATA TO THE CARELINK NETWORK FOR THE CLINIC TO REVIEW. |
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