PMA P910001S088

Device: SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S088
Product code: LPC
Decision date: 2016-10-13
Classification: Device, Angioplasty, Laser, Coronary
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Approval order statement: Replace the vendor of components of the P5 Connector Cable Assembly, the P9 Connector Cable Assembly, and its corresponding 40 pin connector.

Current openFDA PMA Record#

Device: SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
Applicant: Spectranetics Corp.
PMA number: P910001
Supplement: S088
Product code: LPC
Generic name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Decision date: 2016-10-13
Decision code: OK30
Date received: 2016-10-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replace the vendor of components of the P5 Connector Cable Assembly, the P9 Connector Cable Assembly, and its corresponding 40 pin connector.