ENDOTAK(R) SQ LEAD ARRAY MODEL 0048
FDA premarket approval P910073/S003 · decided 1995-04-17
Approval details
- PMA number
- P910073
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDOTAK(R) SQ LEAD ARRAY MODEL 0048
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1994-07-01
- Decision date
- 1995-04-17
- Days to decision
- 290 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.