|
Device | ELCA CORONARY ATHERECTOMY CATHETERS |
Generic Name | DEVICE, ANGIOPLASTY, LASER, CORONARY |
Applicant | SPECTRANETICS CORP. 9965 Federal Drive Colorado Springs, CO 80921 |
PMA Number | P910001 |
Supplement Number | S042 |
Date Received | 01/03/2011 |
Decision Date | 04/20/2011 |
Product Code |
LPC |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO IMPLEMENT THE USE OF AN AUTOMATED METHOD INSTEAD OF A MANUAL METHOD OF DISPENSING EPOXY ADHESIVE. |