FINELINE II STEROX AND STEROX EZ LEADS
FDA premarket approval P960004/S075 · decided 2016-04-29
Approval details
- PMA number
- P960004
- Supplement
- S075
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FINELINE II STEROX AND STEROX EZ LEADS
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 2015-11-20
- Decision date
- 2016-04-29
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the removal of redundant specifications and testing associated with batch release and drug stability testing.
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