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 | 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 | S046 |
Date Received | 05/19/2000 |
Decision Date | 06/13/2000 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement ALTERNATE VENDOR FOR THE BAKE HYPO TUBES USED IN THE MANUFACTURING OF THE ROTABLATOR ROTALINK ADVANCER AND PASSIVATED AT THE VENDOR, AN ADDITIONAL MANUFACTURING STEP FOR THE COMPONENT. |
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