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 | CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P910023 |
Supplement Number | S030 |
Date Received | 09/08/1997 |
Decision Date | 02/02/1998 |
Product Code |
LWS |
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 the Contour(TM) II/Angstrom(TM) II IMplantable Cardioverter/Defibrillator (ICD) System (Contour(TM) II ICD Models V-185, V-185B, V-185C, V-185D and V-185AC, Angstrom(TM) II ICD Models V-180F and V-180HV3, Torque Drive Model AC-TD, DF-1 Receptacle Plug Model AC-DP and PRogrammer Software Version 5.1), a modification to Programmer Software Version 5.1 to allow use with the Ventritex(R) Programmer Model PR-1500, use of the Contour(TM) II and Angstrom(TM) II pulse generator with the Medtronic(R) Transvene(R) Leads, changes in the Contour(TM) II/Angstrom(TM) II Labeling and modifications to PRogrammer Software Version 5.1 to improve the ECG display and theaccuracy of the reported data. |
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