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 | REGENCY PACEMAKERS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P880006 |
Supplement Number | S054 |
Date Received | 10/19/2007 |
Decision Date | 05/16/2008 |
Withdrawal Date
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05/07/2018 |
Product Code |
NVZ |
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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