PMA P910001S103

Device: ELCA Laser Catheters
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S103
Product code: LPC
Decision date: 2018-03-29
Classification: Device, Angioplasty, Laser, Coronary
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Approval order statement: Outsourcing of some tubing components to an already approved supplier and an update of dimensional inspection test methods to implement use of a non-contact measurement system.

Current openFDA PMA Record#

Device: ELCA Laser Catheters
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S103
Product code: LPC
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Decision date: 2018-03-29
Decision code: OK30
Date received: 2018-02-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Outsourcing of some tubing components to an already approved supplier and an update of dimensional inspection test methods to implement use of a non-contact measurement system.