LEAD CAP ACCESSORY KIT
FDA premarket approval P940008/S015 · decided 2000-10-05
Approval details
- PMA number
- P940008
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LEAD CAP ACCESSORY KIT
- Applicant
- Boston Scientific
- Date received
- 2000-06-26
- Decision date
- 2000-10-05
- Days to decision
- 101 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE LEAD CAPS FOR USE WITH ALL GUIDANT COMPATIBLE LEADS INCLUDING THE RELIANCE(TM) AND RELIANCE S(TM) LEADS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.