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 | THINLINE II/FINELINE II STEROX PACING LEADS |
Generic Name | permanent pacemaker Electrode |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960004 |
Supplement Number | S017 |
Date Received | 12/26/2000 |
Decision Date | 02/15/2001 |
Product Codes |
DTB DXY |
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 A MANUFACTURING SITE LOCATED AT GUIDANT PUERTO RICO, DORADO, PUERTO RICO. THE MANUFACTURING SITE WILL PERFORM THE STERILIZATION, PACKAGING AND LABELING OF THE DEVICE. |
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