PUNCTUA ICD, ENEGEN ICD, INCEPTA ICD
FDA premarket approval P960040/S261 · decided 2012-06-19
Approval details
- PMA number
- P960040
- Supplement
- S261
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PUNCTUA ICD, ENEGEN ICD, INCEPTA ICD
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2012-05-11
- Decision date
- 2012-06-19
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODIFYING THE DESIGN SPECIFICATIONS FOR THE SPOT WELD ANCHOR POST USED IN ICD AND CRT-D PULSE GENERATOR (PG) HEADERS AND THE LEAF SPRING HOUSING BLOCK USED IN THE LV-1 FOR CRT-D PULSE GENERATOR HEADERS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.