Sweet TIP® RX Steroid Eluting Lead
FDA premarket approval P960006/S055 · decided 2022-11-02
Approval details
- PMA number
- P960006
- Supplement
- S055
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Sweet TIP® RX Steroid Eluting Lead
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 2022-11-01
- Decision date
- 2022-11-02
- Days to decision
- 1 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Replace laser printers, finished goods box and tray label stock.
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