SWEET TIP RX STEROID ELUTING LEAD
FDA premarket approval P960006/S003 · decided 2000-03-10
Approval details
- PMA number
- P960006
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SWEET TIP RX STEROID ELUTING LEAD
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 1999-12-16
- Decision date
- 2000-03-10
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the use of a modified suture sleeve.
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