FINELINE II PACING LEADS
FDA premarket approval P960004/S023 · decided 2003-12-19
Approval details
- PMA number
- P960004
- Supplement
- S023
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FINELINE II PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 2003-12-03
- Decision date
- 2003-12-19
- Days to decision
- 16 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE ADDITION OF A SPECIFICATION FOR THE CONDUCTOR-TO-TERMINAL PIN WELD STRENGTH.
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