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 KAPPA 900/800 SERIES PLUSE GENERATORS |
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 | S020 |
Date Received | 02/14/2002 |
Decision Date | 02/26/2002 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR ALTERNATE FACILITIES FOR THE MANUFACTURING, PACKAGING AND STERILIZATION OF THE MEDTRONIC KAPPA 900/800 SERIES PULSE GENERATOR PRODUCTS: MEDTRONIC BV, KERKRADE, THE NETHERLANDS AND MEDTRONIC EUROPE S.A., TOLOCHANEZ, SWITZERLAND. |
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