PMA P910001S098
- Device
- ELCA Coronary Laser Atherectomy Catheters
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S098
- Product code
- LPC
- Decision date
- 2017-09-01
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- Changes to the Distal Tip manufacturing and inspection process.
Current openFDA PMA Record#
- Device
- ELCA Coronary Laser Atherectomy Catheters
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S098
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2017-09-01
- Decision code
- OK30
- Date received
- 2017-08-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the Distal Tip manufacturing and inspection process.