ACC STY ITM STR .016 52CM; ACC STY ITM STR .016 45CM; ACC STY ITM STR .014 58CM; ACC STY ITM STR .014 52CM; ACC STY ITM
FDA premarket approval P960004/S110 · decided 2025-09-16
Approval details
- PMA number
- P960004
- Supplement
- S110
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACC STY ITM STR .016 52CM; ACC STY ITM STR .016 45CM; ACC STY ITM STR .014 58CM; ACC STY ITM STR .014 52CM; ACC STY ITM
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 2025-09-05
- Decision date
- 2025-09-16
- Days to decision
- 11 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- for removing an Ethelyne Oxide (EO) chemical indicator dot applied to the outside of sterile packaging pre-sterilization and evaluated visually post-sterilization
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