MODEL 6577 STERILIZABLE TELEMETRY WAND
FDA premarket approval P840068/S015 · decided 1991-11-20
Approval details
- PMA number
- P840068
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 6577 STERILIZABLE TELEMETRY WAND
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1991-07-02
- Decision date
- 1991-11-20
- Days to decision
- 141 days
- Decision code
- APPR
- Product code
- LWP
- 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.