THINLINE II/FINELINE II STEROX PACING LEADS
FDA premarket approval P960004/S018 · decided 2001-04-06
Approval details
- PMA number
- P960004
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THINLINE II/FINELINE II STEROX PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 2001-02-20
- Decision date
- 2001-04-06
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE USE OF MANNITOL AS AN ALTERNATE MATERIAL TO COVER THE HELIX ON THE ABOVE REFERENCED ACTIVE FIXATION PACING LEADS. THE DEVICES ARE INDICATED FOR PERMANENT PACING AND SENSING OF THE ATRIUM AND/OR VENTRICLE WHEN USED WITH A COMPATIBLE PULSE GENERATOR.
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