INCEPTA, ENERGEN, PUNCTUA, TELIGEN ICD'S
FDA premarket approval P960040/S283 · decided 2013-01-10
Approval details
- PMA number
- P960040
- Supplement
- S283
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INCEPTA, ENERGEN, PUNCTUA, TELIGEN ICD'S
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2012-12-12
- Decision date
- 2013-01-10
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADDITION OF AN INSPECTION AT THE SUPPLIER AND UPDATES TO THE CRYSTAL COMPONENT DRAWING.
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