|
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 | S084 |
Date Received | 04/25/2005 |
Decision Date | 05/25/2005 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN ADDITIONAL QUALITY CONTROL (QC) INSPECTION METHOD USING THE PASSAGE OF GUIDEWIRE THROUGH THE ROTALINK PLUS DEVICE LUMEN TO VERIFY THE DEVICE IS FREE FROM OBSTRUCTIONS. |