PMA P910001S019

Device: VITESSE POINT 9 MM X80 & EXTREME POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODELS 110-004 AND 110-002
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S019
Product code: LPC
Decision date: 2001-06-19
Classification: Device, Angioplasty, Laser, Coronary
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
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.

Current openFDA PMA Record#

Device: VITESSE POINT 9 MM X80 & EXTREME POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODELS 110-004 AND 110-002
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S019
Product code: LPC
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Decision date: 2001-06-19
Decision code: APPR
Date received: 2000-12-21
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.