TELIGEN ICDS
FDA premarket approval P960040/S211 · decided 2009-12-23
Approval details
- PMA number
- P960040
- Supplement
- S211
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TELIGEN ICDS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2009-11-27
- Decision date
- 2009-12-23
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A LABELING CHANGE TO INCLUDE A WARNING AGAINST SUB PECTORAL DEVICE IMPLANTATION.
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