PMA P910001

Device: ELCA Coronary Laser Atherectomy Catheters
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S117
Product code: LPC
Decision date: 2026-08-14
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Approval order statement: implementation of an automated inspection method for Excimer Laser Coronary Atherectomy (ELCA) Catheters (P910001) at both the in-process and final inspection steps

Current openFDA PMA Record#

Device: ELCA Coronary Laser Atherectomy Catheters
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S126
Product code: LPC
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Decision date: 2026-08-14
Decision code: APPR
Date received: 2026-03-26
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation of an automated inspection method for Excimer Laser Coronary Atherectomy (ELCA) Catheters (P910001) at both the in-process and final inspection steps