RES-Q(TM) MICRON ICD SYSTEM
FDA premarket approval P940008/S004 · decided 1997-02-28
Approval details
- PMA number
- P940008
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RES-Q(TM) MICRON ICD SYSTEM
- Applicant
- Boston Scientific
- Date received
- 1996-10-22
- Decision date
- 1997-02-28
- Days to decision
- 129 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RES-Q(TM) MICRON MODEL 101-09 AND MDOEL 101-05
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