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 | INSYNC PULSE GENERATOR, INSYNC 3 PULSE GENERATOR |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P010015 |
Supplement Number | S037 |
Date Received | 01/25/2008 |
Decision Date | 02/21/2008 |
Product Code |
LWP |
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 IN THE CLEANING PROCESS FOR TITANIUM SHIELDS AT MEDTRONIC APPROVED SUPPLIER, GTM GLOBE. |
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