PMA P910001S079
- Device
- ELCA CORONARY ATHERECTOMY CATHETERS
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S079
- Product code
- LPC
- Decision date
- 2016-08-31
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Approval for a substitution of the SpectraGlide hydrophilic coating for the TreeFrog hydrophilic coating on the ELCA catheters.
Current openFDA PMA Record#
- Device
- ELCA CORONARY ATHERECTOMY CATHETERS
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S079
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2016-08-31
- Decision code
- APPR
- Date received
- 2015-08-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a substitution of the SpectraGlide hydrophilic coating for the TreeFrog hydrophilic coating on the ELCA catheters.