RES-Q(TM) MICRON ICD SYSTEM
FDA premarket approval P940008/S009 · decided 1998-03-17
Approval details
- PMA number
- P940008
- Supplement
- S009
- 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
- 1997-12-24
- Decision date
- 1998-03-17
- Days to decision
- 83 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for new Models of Res-Q(TM) Micron ICD (Models 101-10 and 101-10A) and modifications to the existing Res-Q(TM) Micron ICD Models 101-05, and 101-09.
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