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 | AFFINITY SR MODELS 5130 (LS,RS,L,R)PULSE GENERATORS AFFINITY DR MODELS 5330 (LS, RS,L,R)PULSE GENERATORS |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S050 |
Date Received | 07/30/1998 |
Decision Date | 01/22/1999 |
Product Code |
DXY |
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 the Affinity DR Model 5330 L/R Dual-Chamber and Affinity SR Model 5130 L/R Single-Chamber Rate-Adaptive Pulse Generators with AutoCapture. The devices, as modified, will be marketed under the trade Affinity DR Model 5330 L/R and Affinity Sr Model 5130 L/R and are indicated for rate-adaptive support pacing. |
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