RES-Q(TM) MICRON ICD SYSTEM
FDA premarket approval P940008/S008 · decided 1997-12-29
Approval details
- PMA number
- P940008
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RES-Q(TM) MICRON ICD SYSTEM
- Applicant
- Boston Scientific
- Date received
- 1997-11-26
- Decision date
- 1997-12-29
- Days to decision
- 33 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a design change to the IS-1 connector of the existing defibrillation/pacing leads.
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