PMA P910001S047
- Device
- ELCA CORONARY ATHERECTOMY CATHETERS
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S047
- Product code
- LPC
- Decision date
- 2012-01-13
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN COLORADO SPRINGS, COLORADO.
Current openFDA PMA Record#
- Device
- ELCA CORONARY ATHERECTOMY CATHETERS
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S047
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2012-01-13
- Decision code
- APPR
- Date received
- 2011-05-09
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN COLORADO SPRINGS, COLORADO.