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 | MICRONY PACEMAKERS |
Generic Name | Pulse-generator, single chamber, sensor driven, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P970013 |
Supplement Number | S021 |
Date Received | 10/19/2007 |
Decision Date | 05/16/2008 |
Product Code |
LWO |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERI-TECH, INC., SALINAS, PUERTO RICO FOR ETHYLENE OXIDE STERILIZATION OF THE PACEMAKERS, ICDS AND LEADS. |
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