PMA P910001S059

Device: EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S059
Product code: LPC
Decision date: 2013-04-04
Classification: Device, Angioplasty, Laser, Coronary
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Approval order statement: APPROVAL FOR A CHANGE TO AN ADHESIVE PRIMER USED IN THE MANUFACTURE OF THE ELCA ECCENTRIC (ELL) DEVICES. PREVIOUSLY, YOU HAVE USED LOCTITE 793 WHICH HAS BEEN DISCONTINUED BY THE VENDOR. THE PRIMER HAS BEEN CHANGED TO LOCTITE 7701, A MEDICAL GRADE ADHESIVE PRIMER USED FOR THE SAME PURPOSE.

Current openFDA PMA Record#

Device: EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S059
Product code: LPC
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Decision date: 2013-04-04
Decision code: APPR
Date received: 2012-07-02
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE TO AN ADHESIVE PRIMER USED IN THE MANUFACTURE OF THE ELCA ECCENTRIC (ELL) DEVICES. PREVIOUSLY, YOU HAVE USED LOCTITE 793 WHICH HAS BEEN DISCONTINUED BY THE VENDOR. THE PRIMER HAS BEEN CHANGED TO LOCTITE 7701, A MEDICAL GRADE ADHESIVE PRIMER USED FOR THE SAME PURPOSE.