PMA P910001S045
- Device
- SPECTRANETICS LASER CATHETERS ELCA
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S045
- Product code
- LPC
- Decision date
- 2011-07-14
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- APPROVAL FOR CHANGES TO PYROGEN TESTING PROCEDURES AND SAMPLING.
Current openFDA PMA Record#
- Device
- SPECTRANETICS LASER CATHETERS ELCA
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S045
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2011-07-14
- Decision code
- APPR
- Date received
- 2011-02-04
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES TO PYROGEN TESTING PROCEDURES AND SAMPLING.