THINLINE II STEROX, FINELINE II STEROX & FINELINE II STEROX EZ LEADS
FDA premarket approval P960004/S050 · decided 2012-02-29
Approval details
- PMA number
- P960004
- Supplement
- S050
- Supplement type
- 30-Day Notice
- Trade name
- THINLINE II STEROX, FINELINE II STEROX & FINELINE II STEROX EZ LEADS
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 2012-01-24
- Decision date
- 2012-02-29
- Days to decision
- 36 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE TO THE BACTERIAL ENDOTOXIN SAMPLING PLAN.
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