SELUTE LEAD SYSTEM
FDA premarket approval P950001/S027 · decided 2014-07-30
Approval details
- PMA number
- P950001
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SELUTE LEAD SYSTEM
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Boston Scientific
- Date received
- 2014-06-30
- Decision date
- 2014-07-30
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE IN THE BIOBURDEN SAMPLING FREQUENCY IN THE CLONMEL AND ST PAUL FACILITIES FOR THE DEVICES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.