ACC SUP FIXATION TOOL
FDA premarket approval P960006/S057 · decided 2025-09-16
Approval details
- PMA number
- P960006
- Supplement
- S057
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACC SUP FIXATION TOOL
- 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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