|
Device | RX 7000 PROGRAMMING SYSTEM |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P830026 |
Supplement Number | S074 |
Date Received | 10/09/1998 |
Decision Date | 02/18/1999 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for Rx7000 Programming System Model 522-17 with R1.00.00 Software. The device, as modified, will be marketed under the trade name Rx7000 Model 522-17 Porgrammer and is indicated for the interrogation and programming of Sulzer Intermedics pulse generators. |