RELIANCE IS-1 FAMILY OF LEADS
FDA premarket approval P910073/S089 · decided 2011-06-14
Approval details
- PMA number
- P910073
- Supplement
- S089
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RELIANCE IS-1 FAMILY OF LEADS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2010-10-29
- Decision date
- 2011-06-14
- Days to decision
- 228 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR ACCEPTANCE OF AN ENHANCEMENT TO THE INSULATION AND TRI-LUMEN BOND PROCESS, TO INCLUDE AN UPGRADE OF THE BONDING EQUIPMENT AND ADDITIONAL ACCEPTANCE ACTIVITY INSPECTIONS TO VERIFY AN ADEQUATE BOND WHICH WILL PREVENT FLUID LEAKAGE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.