| 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 | VITESSE POINT 9 MM X80 & EXTREME POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODELS 110-004 AND 110-002 |
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| Generic Name | DEVICE, ANGIOPLASTY, LASER, CORONARY |
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| Applicant | SPECTRANETICS CORP.
9965 Federal Drive
Colorado Springs, CO 80921 |
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| PMA Number | P910001 |
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| Supplement Number | S019 |
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| Date Received | 12/21/2000 |
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| Decision Date | 06/19/2001 |
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| Product Code |
LPC |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
VITESSE POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODEL 110-004, AND THE EXTREME POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODEL 110-002: 1) A CHANGE IN THE LASTING TIME FROM 5 SECONDS ON AND 10 SECONDS OFF TO 10 SECONDS ON AND 5 SECONDS OFF; 2) A CHANGE IN THE FLUENCE AND REPETITION RATE FROM 30-60 FLUENCE AND 25-40 HZ TO 30-80 FLUENCE AND 25-80 HZ; 3) A LABELING CHANGE FROM "LASER ADVANCEMENT OF APPROXIMATELY 1 MM PER SECOND" TO "MAINTAIN CONSTANT CATHETER TIP CONTACT WITH THE LESION BY APPLYING MILD FORWARD PRESSURE TO THE SHAFT OF THE CATHETER"; AND 4) A CHANGE IN THE PIN CODE ON THE COUPLER SO THAT THE CATHETERS INSTRUCT THE LASER SYSTEM TO ALLOW INCREASED LASING PARAMETERS. |
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