Stylets Models 6053, 6054, 6055
FDA premarket approval P960004/S107 · decided 2025-07-28
Approval details
- PMA number
- P960004
- Supplement
- S107
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Stylets Models 6053, 6054, 6055
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 2025-03-07
- Decision date
- 2025-07-28
- Days to decision
- 143 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- approval for a manufacturing site located at 415 Road 693 Dorado, PR 00646, which manufactures stylet accessories
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