FINELINE II STEROX EZ LEADS
FDA premarket approval P960004/S041 · decided 2008-10-09
Approval details
- PMA number
- P960004
- Supplement
- S041
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FINELINE II STEROX EZ LEADS
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 2008-08-25
- Decision date
- 2008-10-09
- Days to decision
- 45 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE MANNITOL BULLET FORMING FIXTURE AND LEAD TIP PROTECTOR FOR THE DEVICE.
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