ENDOTAK RELIANCE G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS, ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS
FDA premarket approval P910073/S130 · decided 2015-07-16
Approval details
- PMA number
- P910073
- Supplement
- S130
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDOTAK RELIANCE G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS, ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2015-06-22
- Decision date
- 2015-07-16
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LWS
- 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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