|
Device | PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | BOSTON SCIENTIFIC One Scimed Place Maple Grove, MN 55311 |
PMA Number | P880027 |
Supplement Number | S058 |
Date Received | 02/27/2001 |
Decision Date | 03/27/2001 |
Withdrawal Date
|
04/13/2007 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE FROM AN INTERNAL PARTICULATE MAXIMUM LEVEL TO AN INTERNAL PARTICULATE ACTION LEVEL OF 75,000 PARTICLES >=10 MICRONS FOR THE FINISHED PRODUCT. |