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 | SOLUS(TM) MODEL 2002L & SYNCHRONY II MODEL 2022L |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S010 |
Date Received | 03/29/1991 |
Decision Date | 01/11/1993 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR RELOCATING THE MANUFACTURING FACILITIES TO 15900 VALLEYVIEW COURT, SYLMAR, CALIFORNIA, 91392-9221 |
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