INSIGNIA/NEXUS, PRIZM/VITALITY & CONTAK RENEWAL FAMILIES
FDA premarket approval P960040/S116 · decided 2006-04-21
Approval details
- PMA number
- P960040
- Supplement
- S116
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INSIGNIA/NEXUS, PRIZM/VITALITY & CONTAK RENEWAL FAMILIES
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2006-03-23
- Decision date
- 2006-04-21
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- IMPLEMENTATION OF ADDITIONAL PRODUCTS ON EXISTING INNER LEAD BONDING (ILB) MACHINES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.