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PHOTON MICRO(U) DR/VR MODELS V-232/V-194 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 3307 PROGRAMMER SOFTW3

FDA premarket approval P910023/S052 · decided 2001-06-13

Approval details

PMA number
P910023
Supplement
S052
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
PHOTON MICRO(U) DR/VR MODELS V-232/V-194 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 3307 PROGRAMMER SOFTW3
Generic name
Implantable cardioverter defibrillator (non-CRT)
Applicant
ABBOTT MEDICAL
Date received
2001-05-09
Decision date
2001-06-13
Days to decision
35 days
Decision code
APPR
Product code
LWS
Advisory committee
Cardiovascular
Expedited review
No
Location
Sylmar, CA
Statement
APPROVAL FOR PHOTON(TM) MICRO (U) DR/VR MODELS V-232/V-194 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WITH MODEL 3307 PROGRAMMER SOFTWARE, V2.3. THESE DEVICES ARE INTENDED TO PROVIDE VENTRICULAR ANTI-TACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.

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