|
Device | ANGIOSCULPT PTCA SCORING BALLOON CATHETER |
Generic Name | Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring |
Applicant | SPECTRANETICS CORP. 5055 BRANDIN COURT FREMONT, CA 94538 |
PMA Number | P050018 |
Supplement Number | S011 |
Date Received | 10/12/2010 |
Decision Date | 12/29/2010 |
Product Code |
NWX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE TO INCREASE THE LOAD DENSITY FOR ETHYLENE OXIDE STERILIZATION OF THE ABOVE-STATED DEVICE. |