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. |
|
Device | ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S072 |
Date Received | 05/20/2002 |
Decision Date | 06/27/2002 |
Product Code |
MCX |
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 BOSTON SCIENTIFIC CORPORATION CORK, LTD. (BSCL), CORK, IRELAND, AS THE MANUFACTURING FACILITY FOR THE MOLDED SHUTTLE SEAL AND LIP SEAL COMPONENTS OF THE ROTABLATOR DEVICES. |
|
|