PMA P910001S076
- Device
- SPECTRANETICS EXCIMER CORONARY LASER ATHERECTOMY (ELCA) CATHETERS
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S076
- Product code
- LPC
- Decision date
- 2015-01-08
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- CHANGE TO AUTOMATE THE PIN CUTTING PROCESS ON THE PROXIMAL HANDLE WHICH IS CURRENTLY PERFORMED MANUALLY.
Current openFDA PMA Record#
- Device
- SPECTRANETICS EXCIMER CORONARY LASER ATHERECTOMY (ELCA) CATHETERS
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S076
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2015-01-08
- Decision code
- OK30
- Date received
- 2014-12-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO AUTOMATE THE PIN CUTTING PROCESS ON THE PROXIMAL HANDLE WHICH IS CURRENTLY PERFORMED MANUALLY.