FINELINE II STEROX LEADS
FDA premarket approval P960004/S020 · decided 2001-12-18
Approval details
- PMA number
- P960004
- Supplement
- S020
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FINELINE II STEROX LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 2001-11-16
- Decision date
- 2001-12-18
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR USE OF DEXAMETHASONE ACETATE (DXA) AS AN ALTERNATE STEROID COLLAR ON THE FINELINE II STEROX LEAD MODELS 4456, 4457, 4458, 4459, 4469, 4470, 4471, 4472, 4473, 4479 AND 4480.
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