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 GEM DR MODEL 7271 |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980016 |
Supplement Number | S020 |
Date Received | 08/06/2001 |
Decision Date | 09/05/2001 |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ALTERNATE MANUFACTURING AND STERILIZATION FACILITY LOCATED AT MEDTRONIC EUROPE S.A., TOLOCHENAZ, SWITZERLAND AND AN ALTERNATE PACKAGING FACILITY LOCATED AT MEDTRONIC BV, KERKRADE, THE NETHERLANDS. |
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