FINELINE
FDA premarket approval P960004/S005 · decided 1999-07-01
Approval details
- PMA number
- P960004
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FINELINE
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 1999-06-14
- Decision date
- 1999-07-01
- Days to decision
- 17 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the ThinLine(TM) pacing leads under the Guidant FINELINE(TM) trade name. These devices are indicated for permanent pacing and sensing in the ventricle and/or the atrium when used with a compatible pulse generator.
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