PMA P910001S042
- Device
- ELCA CORONARY ATHERECTOMY CATHETERS
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S042
- Product code
- LPC
- Decision date
- 2011-04-20
- Classification
- Device, Angioplasty, Laser, Coronary
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Approval order statement
- APPROVAL TO IMPLEMENT THE USE OF AN AUTOMATED METHOD INSTEAD OF A MANUAL METHOD OF DISPENSING EPOXY ADHESIVE.
Current openFDA PMA Record#
- Device
- ELCA CORONARY ATHERECTOMY CATHETERS
- Applicant
- Spectranetics Corp.
- PMA number
- P910001
- Supplement
- S042
- Product code
- LPC
- Generic name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- Decision date
- 2011-04-20
- Decision code
- APPR
- Date received
- 2011-01-03
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO IMPLEMENT THE USE OF AN AUTOMATED METHOD INSTEAD OF A MANUAL METHOD OF DISPENSING EPOXY ADHESIVE.