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 | ROTAGLIDE(TM) LUBRICANT |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S045 |
Date Received | 05/18/2000 |
Decision Date | 06/06/2000 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGES IN THE MANUFACTURING PROCESS, REMOVING ONE OF THE STEPS FROM THE RELEASE CRITERIA FOR ROTAGLIDE(TM) LUBRICANT, TO MOVE THE PACKAGING INSPECTION AND REVIEW OF THE CERTIFICATE OF ANALYSIS FROM BOSTON SCIENTIFIC CORP. NORTHWEST TO BOSTON SCIENTIFIC CORP'S MARINA BAY DISTRIBUTION CENTER IN QUINCY, MASSECHUSETTS. |
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