SWEET TIP(R) RX STEROID ELUTING LEAD
FDA premarket approval P960006/S052 · decided 2021-05-10
Approval details
- PMA number
- P960006
- Supplement
- S052
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SWEET TIP(R) RX STEROID ELUTING LEAD
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 2021-04-30
- Decision date
- 2021-05-10
- Days to decision
- 10 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Add a new pallet sterilization chamber at the Arden Hills facility to increase sterilization capacity.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.