FINELINE II STEROX LEAD
FDA premarket approval P960004/S060 · decided 2013-09-09
Approval details
- PMA number
- P960004
- Supplement
- S060
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FINELINE II STEROX LEAD
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 2013-06-26
- Decision date
- 2013-09-09
- Days to decision
- 75 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL TO CHANGE THE PRIMER FORMULATION USED ON FINELINE II LEADSUBASSEMBLIES, AS WELL AS TO RELOCATE MANUFACTURING OF SOME SUBASSEMBLIES IN-HOUSE WITH MINOR ASSOCIATED DESIGN CHANGES.
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