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 | INTERTACH |
Generic Name | PULSE-GENERATOR, SINGLE CHAMBER, SINGLE |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P860007 |
Supplement Number | S024 |
Date Received | 03/26/2012 |
Decision Date | 04/23/2012 |
Withdrawal Date
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07/19/2012 |
Product Code |
LWW |
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 IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL. |
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