IS-1 CONNECTOR TERMINAL OF SELUTE/PICOTIP BIPOLAR LEADS
FDA premarket approval P950001/S006 · decided 2000-05-19
Approval details
- PMA number
- P950001
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IS-1 CONNECTOR TERMINAL OF SELUTE/PICOTIP BIPOLAR LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 2000-04-17
- Decision date
- 2000-05-19
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for: 1) use of a new mechanically interlocking component design to connect the terminal pin to the terminal ring, and 2) use of a shorter IS-1 connector terminal.
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