FINELINE 2 PACING LEADS
FDA premarket approval P960004/S070 · decided 2015-07-16
Approval details
- PMA number
- P960004
- Supplement
- S070
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FINELINE 2 PACING LEADS
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 2015-06-22
- Decision date
- 2015-07-16
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADD AN AUTOMATED VISION SYSTEM LABEL INSPECTION TO THE FINAL PACKAGING LINE, REMOVE REDUNDANT IN-PROCESS INSPECTION AND MOVE UPSTREAM VALIDATED INSPECTIONS TO A DOWNSTREAM STEP.
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