SELUTE LEAD FAMILY
FDA premarket approval P950001/S024 · decided 2012-11-09
Approval details
- PMA number
- P950001
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SELUTE LEAD FAMILY
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Boston Scientific
- Date received
- 2012-10-02
- Decision date
- 2012-11-09
- Days to decision
- 38 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.