THINLINE II/ FINELINE II
FDA premarket approval P960004/S014 · decided 2000-11-21
Approval details
- PMA number
- P960004
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THINLINE II/ FINELINE II
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 2000-05-26
- Decision date
- 2000-11-21
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE SILICONE AND POLYURETHANE THINLINE(TM) II STEROX AND FINELINE(TM) II STEROID ELUTING PACING LEADS. THE DEVICES ARE INDICATED FOR CHRONIC PACING AND SENSING OF THE VENTRICLE AND/OR ATRIUM WHEN USED WITH A COMPATIBLE PULSE GENERATOR.
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