FINELINE II STEROX AND STEROX EZ ENDOCARDIAL PACING LEAD
FDA premarket approval P960004/S059 · decided 2015-10-08
Approval details
- PMA number
- P960004
- Supplement
- S059
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FINELINE II STEROX AND STEROX EZ ENDOCARDIAL PACING LEAD
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 2013-03-27
- Decision date
- 2015-10-08
- Days to decision
- 925 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE FOLLOWING:1) A STERILIZATION PROCESS CHANGE FROM OXYFUME TO 100% ETHYLENE OXIDE;2) DRUG SPECIFICATION CHANGES; 3) LABELING CHANGES; 4) TO FINISH REMAINING 3 MONTHS OF LOT RELEASE STUDY FOR PASSIVE FIXATION LEADS AS NON-CLINICAL POST APPROVAL STUDY;4) MANUFACTURING CHANGES TO REDUCE ELUTION VARIATION;5) TO UPDATE ACTIVE FIXATION BATCH RELEASE STUDY PROTOCOL TO IMPLEMENT NEW MANUFACTURING CHANGES; AND6) TO COMPLETE 12 MONTH LOT RELEASE STUDY AS NON-CLINICAL POST APPROVAL STUDY.
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