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 | BARD ABLATION SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 55 TECHNOLOGY DRIVE LOWELL, MA 01851 |
PMA Number | P000020 |
Supplement Number | S016 |
Date Received | 10/05/2012 |
Decision Date | 11/13/2012 |
Withdrawal Date
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01/12/2024 |
Product Code |
LPB |
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 CHANGES TO THE ELECTRICAL TESTER AND BARCODE SCANNER. |
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