|
Device | SPECTRANETICS LASER SHEATH (SLSII) |
Generic Name | DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS |
Applicant | Spectranetics (Philips) 9965 Federal Drive Colorado Springs, CO 80921 |
PMA Number | P960042 |
Supplement Number | S023 |
Date Received | 11/22/2010 |
Decision Date | 11/18/2011 |
Product Code |
MFA |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A STERILIZATION SITE LOCATED AT CARIDIANBCT STERILIZATION SERVICES IN LAKEWOOD, COLORADO. |