Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | CHILLI COOLED ABLATION SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 2710 ORCHARD PKWY. SAN JOSE, CA 95113 |
PMA Number | P990054 |
Supplement Number | S003 |
Date Received | 12/26/2001 |
Decision Date | 01/08/2002 |
Withdrawal Date
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07/28/2006 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ADDITIONAL MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC CORPORATION, SAN JOSE, CALIFORNIA. |
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