Medical Adhesive Model 6517
FDA premarket approval P830060/S090 · decided 2024-01-19
Approval details
- PMA number
- P830060
- Supplement
- S090
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Medical Adhesive Model 6517
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2023-09-22
- Decision date
- 2024-01-19
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a manufacturing site located at Prince Sterilization Services LLC, 16 Montesano Road, Fairfield, NJ 07004-3310. Prince Sterilization Services LLC will conduct dry heat sterilization of the Medical Adhesive Model 6517, and the Medical Adhesive in the Lead Repair Kit Model 6946.
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