PMA P910001S024

Device: SPECTRANECTICS VITESSE COS RX CATHETERS, VITESSE E CATHETERS AND EXTREME OTW CATHETERS
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S024
Product code: LPC
Decision date: 2003-08-08
Classification: Device, Angioplasty, Laser, Coronary
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Approval order statement: APPROVAL FOR CHANGES TO INSTRUCTIONS FOR USE, INCLUDING CHANGES TO THE CONTRAINDICATIONS SECTION, FOR THE VITESSE COS RX, VITESSE E, AND EXTREME OTW CATHETERS.

Current openFDA PMA Record#

Device: SPECTRANECTICS VITESSE COS RX CATHETERS, VITESSE E CATHETERS AND EXTREME OTW CATHETERS
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S024
Product code: LPC
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Decision date: 2003-08-08
Decision code: APPR
Date received: 2003-02-10
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES TO INSTRUCTIONS FOR USE, INCLUDING CHANGES TO THE CONTRAINDICATIONS SECTION, FOR THE VITESSE COS RX, VITESSE E, AND EXTREME OTW CATHETERS.