Lead Repair Kit Model 6946
FDA premarket approval P910073/S175 · decided 2024-01-19
Approval details
- PMA number
- P910073
- Supplement
- S175
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Lead Repair Kit Model 6946
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.