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 | MODEL 2901 PROGRAMMER |
Generic Name | Programmer, pacemaker |
Regulation Number | 870.3700 |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S014 |
Date Received | 03/25/1996 |
Decision Date | 11/07/1996 |
Product Code |
KRG |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A 1)NEW PROGRAMMING SYSTEM, THE MODEL 2901 PRM PROGRAMMING SYSTEM WITH THE COMMERCIALLY AVAILABLE VENTAK PRXII/PRXIII, MINI PULSE GENERTORS AND ACCESSORIES, AND 2) A NEW MANUFACTURING CONTRACT FACILITY, EMD ASSOCIATES, INC. (EMD), 4065 THEURER BLVD., WINONA, MN 55987 |
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