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 | INTEGRITY/BRADYCARDIA REFERENCE/PATIENT MANUAL |
Generic Name | Programmer, pacemaker |
Regulation Number | 870.3700 |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P830045 |
Supplement Number | S072 |
Date Received | 09/22/2000 |
Decision Date | 10/02/2000 |
Withdrawal Date
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06/20/2007 |
Product Code |
KRG |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE USERS MANUALS FOR THE INTEGRITY AFX DR MODEL 5342 AND SR MODEL 5142. |
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