VITESSE POINT 9 MM X80 & EXTREME POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODELS 110-004 AND 110-002

FDA premarket approval P910001/S019 · decided 2001-06-19

Approval details

PMA number

P910001

Supplement

S019

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

VITESSE POINT 9 MM X80 & EXTREME POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODELS 110-004 AND 110-002

Generic name

DEVICE, ANGIOPLASTY, LASER, CORONARY

Applicant

Spectranetics Corp.

Date received

2000-12-21

Decision date

2001-06-19

Days to decision

180 days

Decision code

APPR

Product code

LPC

Advisory committee

Cardiovascular

Expedited review

No

Location

Colorado Springs, CO

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 C

510(k) clearances by this applicant