FINELINE II/THINLINE II STEROX LEADS
FDA premarket approval P960004/S039 · decided 2007-04-18
Approval details
- PMA number
- P960004
- Supplement
- S039
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FINELINE II/THINLINE II STEROX LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Boston Scientific
- Date received
- 2007-03-19
- Decision date
- 2007-04-18
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR ELECTRODE TIP COMPONENT MODIFICATIONS AND MEDICAL ADHESIVE REPLACEMENT.
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