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 | REGENCY SC+ PULSE GENERATORS |
Generic Name | Programmer, pacemaker |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P880006 |
Supplement Number | S034 |
Date Received | 09/28/2001 |
Decision Date | 10/25/2001 |
Withdrawal Date
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05/07/2018 |
Product Codes |
DXY KRG |
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 ELIMINATION OF THE IN-PROCESS X-RAY IMAGING OF THE MICRONY AND REGENCY SC+ PULSE GENERATORS. |
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