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 | BRAVA CRT-D, BRAVA QUAD CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROCETA XT CRT-D, VIVA QUAD S CRT-D, VIVA QUARD XT CRT-D |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S528 |
Date Received | 02/02/2016 |
Decision Date | 03/01/2016 |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Implementation of routine bacterial endotoxin testing. |
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