|
Device | EP TECH EPT-1000XP RF ABLATION SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St Paul, MN 55112 |
PMA Number | P020025 |
Supplement Number | S015 |
Date Received | 10/13/2005 |
Decision Date | 07/08/2009 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT STELLARTECH RESEARCH CORPORATION, SUNNYVALE, CALIFORNIA. |