ATRIAL J SELUTE PICOTIP STEROID ELUTING LEAD
FDA premarket approval P950001/S007 · decided 2000-06-29
Approval details
- PMA number
- P950001
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ATRIAL J SELUTE PICOTIP STEROID ELUTING LEAD
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 2000-05-31
- Decision date
- 2000-06-29
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR CHANGES TO THE LEAD STABILIZER COMPONENT.
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