VITALITY AND CONFIENT
FDA premarket approval P960040/S207 · decided 2009-12-22
Approval details
- PMA number
- P960040
- Supplement
- S207
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITALITY AND CONFIENT
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2009-11-19
- Decision date
- 2009-12-22
- Days to decision
- 33 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADDITION OF A NIKON OPTICAL SYSTEM TO THE PROCESS MONITORING STEP.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.