|
Device | ETHYLENE OXIDE (EO)STERILIZATION EQUIPMENT |
Generic Name | DEVICE, ANGIOPLASTY, LASER, CORONARY |
Applicant | SPECTRANETICS CORP. 9965 Federal Drive Colorado Springs, CO 80921 |
PMA Number | P910001 |
Supplement Number | S017 |
Date Received | 09/28/1999 |
Decision Date | 03/17/2000 |
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 |
Approval Order Statement The 135-day supplement requested approval for the addition of ethylene oxide sterilization equipment. |