PMA P910001

Device: ELCA Coronary Atherectomy Catheters
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S117
Product code: LPC
Decision date: 2026-02-06
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Approval order statement: the use of alternate components in the adhesive supplied to Philips/Spectranetics for the sterile barrier of the packaging system

Current openFDA PMA Record#

Device: ELCA Coronary Atherectomy Catheters
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S124
Product code: LPC
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Decision date: 2026-02-06
Decision code: APPR
Date received: 2025-06-17
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the use of alternate components in the adhesive supplied to Philips/Spectranetics for the sterile barrier of the packaging system