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 | SWEET TIP RX STEROID ELUTING LEAD |
Generic Name | permanent pacemaker Electrode |
Regulation Number | 870.3680 |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960006 |
Supplement Number | S004 |
Date Received | 08/21/2000 |
Decision Date | 09/25/2000 |
Product Code |
DTB |
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 A MANUFACTURING SITE LOCATED AT AN ALTERNATE FACILITY FOR STERILIZATION, PACKAGING AND LABELING AT GUIDANT PUERTO RICO, DORADO, PUERTO RICO. |
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