|
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 | S082 |
Date Received | 12/27/2004 |
Decision Date | 02/09/2005 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE DIRECTIONS FOR USE (DFU) MANUAL FOR THE ROTABLATOR CONSOLE UNIT. THE CHANGES INCLUDE REMOVAL OF THE REFERENCES TO THE CONSOLE RECORDER CONNECTION, UPDATES TO THE CONTACT INFORMATION AND CATALOG NUMBERS, AND OTHER MINOR CLARIFICATIONS. |