RELIANCE 4-SITE DEFIBRILLATOR LEAD
FDA premarket approval P910073/S107 · decided 2012-12-20
Approval details
- PMA number
- P910073
- Supplement
- S107
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RELIANCE 4-SITE DEFIBRILLATOR LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2012-09-28
- Decision date
- 2012-12-20
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR DRUG MATERIAL AND SUPPLIER CHANGES AS WELL AS DISTAL TIP DESIGN CHANGES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.