PMA P910001S026

Device: SPECTRANETICS CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S026
Product code: LPC
Decision date: 2007-05-11
Classification: Device, Angioplasty, Laser, Coronary
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Approval order statement: APPROVAL FOR THE REMOVAL OF A COATING ON THE INNER LUMEN OF THE EXTREME CATHETER MODEL NUMBERS 114-001, 117-002, AND 120-001, THE CHANGE TO BLACK TUBING FOR 0.9 MM CATHETER MODEL NUMBERS 110-003 AND 110-004 X-80, AND THE CHANGE IN THE STRAIN RELIEF MATERIAL DUROMETER FOR THE 0.9 MM EXTREME CATHETER MODEL NUMBERS 110-001, 110-002, 110-152 AND 0.7 MM EXTREME CATHETER MODEL 110-005 TO PREVENT KINKING AT THE STRAIN RELIEF.

Current openFDA PMA Record#

Device: SPECTRANETICS CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S026
Product code: LPC
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Decision date: 2007-05-11
Decision code: APPR
Date received: 2006-11-16
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE REMOVAL OF A COATING ON THE INNER LUMEN OF THE EXTREME CATHETER MODEL NUMBERS 114-001, 117-002, AND 120-001, THE CHANGE TO BLACK TUBING FOR 0.9 MM CATHETER MODEL NUMBERS 110-003 AND 110-004 X-80, AND THE CHANGE IN THE STRAIN RELIEF MATERIAL DUROMETER FOR THE 0.9 MM EXTREME CATHETER MODEL NUMBERS 110-001, 110-002, 110-152 AND 0.7 MM EXTREME CATHETER MODEL 110-005 TO PREVENT KINKING AT THE STRAIN RELIEF.