INTERTACH II MODELS 262-16
FDA premarket approval P860007/S020 · decided 1998-07-06
Approval details
- PMA number
- P860007
- Supplement
- S020
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTERTACH II MODELS 262-16
- Generic name
- PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
- Applicant
- Boston Scientific
- Date received
- 1998-05-19
- Decision date
- 1998-07-06
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- LWW
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for alternate Polyethylene Terephthalate Glycol (PETG) packaging material for the Intetach II, Model 262-16 pulse generator.
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