IS-1 CONNECTOR TERMINAL MODEL 6952 LEAD EXTENDER
FDA premarket approval P910073/S033 · decided 2000-09-12
Approval details
- PMA number
- P910073
- Supplement
- S033
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IS-1 CONNECTOR TERMINAL MODEL 6952 LEAD EXTENDER
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2000-07-12
- Decision date
- 2000-09-12
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR INTERNAL COMPONENT CHANGES TO THE IS-1 CONNECTOR TERMINAL OF THE MODEL 6952 LEAD EXTENDER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.