THINELINE/FINELINE II ENDOCARDIAL PACING LEADS
FDA premarket approval P960004/S006 · decided 2000-01-07
Approval details
- PMA number
- P960004
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THINELINE/FINELINE II ENDOCARDIAL PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 1999-06-23
- Decision date
- 2000-01-07
- Days to decision
- 198 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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