FINELINE II/THINLINE II BRADY LEADS
FDA premarket approval P960004/S042 · decided 2009-06-05
Approval details
- PMA number
- P960004
- Supplement
- S042
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FINELINE II/THINLINE II BRADY LEADS
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 2008-12-08
- Decision date
- 2009-06-05
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE ADDITION OF A NEW SUPPLIER, OPTINOVA, AND CHANGES IN SPECIFICATIONS FOR FOREIGN MATTER, GELS, AND BUBBLES FOR THE POLYURETHANE TUBING LEAD BODY USED IN THE DEVICE.
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