PMA P910001S072
- Device
- EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S072
- Product code
- LPC
- Decision date
- 2014-10-09
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- APPROVAL FOR PARAMETRIC RELEASE FOR THE EXCIMER LASER CORONARY ATHERECTOMY CATHETER AND SPECTRANETICS LASER SHEATH KITS.
Current openFDA PMA Record#
- Device
- EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S072
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2014-10-09
- Decision code
- APPR
- Date received
- 2014-07-14
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR PARAMETRIC RELEASE FOR THE EXCIMER LASER CORONARY ATHERECTOMY CATHETER AND SPECTRANETICS LASER SHEATH KITS.